Marketing application also submitted to European Health Authorities
HORSHAM, Pa., Dec. 20, 2010 /PRNewswire/ -- Centocor Ortho Biotech Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. Janssen-Cilag International NV also filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate. Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Abiraterone acetate is an investigational oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies. This is also known as castration-resistant prostate cancer (CRPC). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumor.
Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301), which evaluated overall survival and tolerability in patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. In September 2010, the company announced that the study was unblinded on the recommendation of an Independent Data Monitoring Committee.
Data from this 1,195 patient study conducted in 147 centers in 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO) Congress in October 2010. Additional ongoing studies are currently underway for abiraterone acetate.
"These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company," said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. "We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor microenvironment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients."
If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.
About Metastatic Advanced Prostate Cancer
Prostate cancer is considered to be advanced when metastases beyond the prostate occur and when resistance emerges to conventional hormonal therapies. Metastatic advanced prostate cancer is also referred to as castration-resistant prostate cancer, or CRPC, when disease progresses despite conventional hormone therapies or appearance of new metastases.
Prostate cancer occurs when cancer cells form in the tissues of the prostate. The prostate is a gland located around the urethra (under the bladder) in men that produces part of the seminal fluid. In some cases, cancer of the prostate can grow slowly compared with other cancers. However, depending on factors including characteristics specific to the patient and the tumor, prostate cancer can also grow very quickly and spread widely.
Prostate cancer is the second most common type of cancer in American men. One in six men will be diagnosed with prostate cancer, and in the United States in 2009, nearly 200,000 men were diagnosed with the disease. In 2010, an estimated 217,000 new cases of prostate cancer and 32,000 related deaths are expected to be reported in the United States.
About Centocor Ortho Biotech Inc.
Centocor Ortho Biotech Inc. redefines the standard of care in immunology, nephrology and oncology. The company was formed when Centocor, Inc. and Ortho Biotech Inc. were consolidated in late 2008, and was renamed Centocor Ortho Biotech Inc. Built upon a pioneering history, Centocor Ortho Biotech Inc. harnesses innovations in large-molecule and small-molecule research to create important new therapeutic options. Beyond its innovative medicines, Centocor Ortho Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care. For more information about Centocor Ortho Biotech, visit www.centocororthobiotech.com.
About Janssen
Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).
Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
More information can be found at www.janssen-emea.com.
About Johnson & Johnson Pharmaceutical Research & Development
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) is a subsidiary of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, N.J., and has facilities throughout the United States, Europe and Asia. J&JPRD is focusing its drug discovery and drug development efforts to address unmet medical needs worldwide in a variety of therapeutic areas including cardiovascular and metabolic diseases, oncology, immunology, central nervous system disorders and virology. More information can be found at http://www.jnjpharmarnd.com.
About Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology, Inc.
Ortho Biotech Oncology Research & Development, unit of Cougar Biotechnology, Inc., partners with affiliated units and companies in the Janssen Pharmaceutical Companies of Johnson & Johnson, such as Centocor Ortho Biotech Inc. and J&JPRD, in the research and development of oncology and supportive care treatments.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Centocor Ortho Biotech Inc., J&JPRD, Janssen-Cilag International or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
*Editor's Note: J&JPRD has initiated an early access program (EAP) for abiraterone acetate in metastatic advanced prostate cancer patients who have exhausted currently approved treatment options including docetaxel and are likely to benefit from the therapy. For information about early access to abiraterone acetate, please call 1-800-457-6399.
Tuesday, December 21, 2010
Tuesday, December 7, 2010
Aspirin Therapy and Seniors'\Sexual Activity
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Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief
physician's first watch
Poll results are in!
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Sex Remains Important to Many Elderly Men
NIH Issues Guidelines on Managing Food Allergies
Featured in Journal Watch: Suicide Attempts in the Population — What Counts?
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.
Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)
Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).
In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.
Lancet article (Free abstract)
Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)
Sex Remains Important to Many Elderly Men
Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.
Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)
Among the findings:
Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.
Annals of Internal Medicine article (Free abstract)
Share: Digg this Add to del.icio.us Add to Reddit Forward to a friend Top
Forward | Sign Up | My Alerts | About Physician's First Watch | Editorial Board
Physician's First Watch for December 7, 2010
David G. Fairchild, MD, MPH, Editor-in-Chief
physician's first watch
Poll results are in!
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Sex Remains Important to Many Elderly Men
NIH Issues Guidelines on Managing Food Allergies
Featured in Journal Watch: Suicide Attempts in the Population — What Counts?
Daily Aspirin Associated with Reduced Cancer Mortality in Meta-Analysis
Daily aspirin use confers a reduction in risk for death from several common cancers, in addition to its known benefit on colorectal cancer risk, according to a Lancet meta-analysis.
Researchers pooled data from eight studies including some 25,000 individuals assigned to daily aspirin or control therapy for at least 4 years. (The studies originally investigated aspirin's effects on cardiovascular events.)
Overall, aspirin recipients showed a lower odds ratio for cancer deaths during the trials; when individual patient data were available (on some 23,500 patients), the decrease appeared only after 5 years of aspirin use. The apparent benefit increased with duration of treatment, was not related to daily dose, and seemed confined to adenocarcinomas (e.g., esophageal and lung).
In three U.K. trials, cancer registries were used to extend follow-up to establish 20-year risks, which remained lower among aspirin recipients even after the end of their trial participation.
Lancet article (Free abstract)
Physician's First Watch coverage of study showing link between low-dose aspirin and reduced colorectal cancer risk (Free)
Sex Remains Important to Many Elderly Men
Roughly half of elderly men consider sex to be at least somewhat important to them, according to an Annals of Internal Medicine study.
Some 3000 community-dwelling men aged 75 to 95 in Australia completed questionnaires about sexual activity and health conditions. (The men also underwent sex-hormone measurement several years earlier.)
Among the findings:
Overall, 30% reported having sex in the previous year; the prevalence was highest among the youngest men (40% among 70- to 79-year-olds vs. 11% among 90- to 95-year-olds).
Of those who reported being sexually active, more than half were satisfied with the frequency.
Independent predictors of not being active included a diagnosis of prostate cancer, osteoporosis, or diabetes; antidepressant or beta-blocker use; and lack of interest or physical limitations of one's partner.
Higher free testosterone levels were associated with increased odds of activity.
Annals of Internal Medicine article (Free abstract)
Share: Digg this Add to del.icio.us Add to Reddit Forward to a friend Top
Wednesday, December 1, 2010
Prostate Cancer Roundtable Optimistic that ODAC will Recommend Approval of
Dutasteride for Prostate Cancer Prevention
Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.
Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”
The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.
“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”
The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).
Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.
The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.
“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”
As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.
Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”
About Prostate Cancer
Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.
About Dutasteride
Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.
Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.
In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).
About the Prostate Cancer Roundtable
The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.
###
The above statement has been issued on behalf of and endorsed by
American Urological Association Foundation
Dutasteride for Prostate Cancer Prevention
Washington, DC, November 30, 2010 – On Wednesday, December 1, the U.S. Food
and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC)
will hear presentations about the effectiveness and safety of dutasteride in
reduction of the risk for prostate cancer in men at greater than average
risk of such a diagnosis – and then decide whether to recommend approval of
dutasteride for this new indication.
Speaking on behalf of the entire Prostate Cancer Roundtable, Dan Zenka, a
vice president of the Santa Monica-based Prostate Cancer Foundation, said,
“We are optimistic that ODAC will send a strong signal to the FDA that the
benefits of dutasteride as an agent for the prevention of prostate cancer
far outweigh the known side effects of this agent. Dutasteride is a drug
that has been widely used for many years by hundreds and thousands of men as
a treatment for benign prostatic hyperplasia.”
The ability to significantly reduce lifetime risk for selected forms of
cancer is dependent, in part, on our ability to develop and bring to market
agents that can clearly reduce that risk -- in the same way that
cholesterol-lowering agents have been able to reduce risk for certain types
of cardiovascular disease. To date, only two drugs have ever been approved
for the prevention of any form of cancer -- tamoxifen and raloxifene -- each
of which is approved for the reduction of risk from invasive forms of breast
cancer in well-defined patient types.
“It is important to note that prostate cancer can have a devastating effect
on entire families,” said Theresa Morrow of Women Against Prostate Cancer.
“Just a little encouragement from a spouse or another family member can get
a man to his healthcare provider for regular health checks, including
prostate cancer testing when appropriate. The approval of a drug that can
help to reduce risk for prostate cancer would be another positive message in
the continuing battle to improve men’s health.”
The 8,200-patient REDUCE trial was a double-blind, randomized,
placebo-controlled, multi-center study that evaluated whether dutasteride --
at a daily dose of 0.5 mg -- decreased risk of biopsy-detectable prostate
cancer by comparison with a placebo. The patients tested in the REDUCE trial
were men between the ages of 50 and 75 who were at increased risk for
prostate cancer because of prostate specific antigen (PSA) levels between
2.5 and 10 ng/ml (in men aged 50 to 60 years) and between 3.0 and 10.0 ng/mL
(in men aged greater than 60 years).
Results from the REDUCE trial were initially presented at the annual meeting
of the American Urological Association in April 2009 and subsequently
reported in the New England Journal of Medicine. They showed that
dutasteride lowered the relative risk of developing prostate cancer by 23
percent in men with an increased risk of the disease. The absolute reduction
in risk for a diagnosis of prostate cancer associated with dutasteride as
compared to a placebo was 5.2 percent.
The REDUCE trial clearly achieved its primary endpoint and demonstrated that
dutasteride significantly reduced the risk of biopsy-detectable prostate
cancers over a period of just 4 years. A total of 1,516 cancers were
identified among the 6,729 men who underwent a biopsy or prostate surgery,
with 659 in the dutasteride arm and 857 in the placebo arm.
“The approval of dutasteride for the prevention of prostate cancer
represents an important opportunity for men known to be at elevated risk for
this disorder,” said Tom Kirk, president of Us TOO International, the
world’s largest, patient-focused, prostate cancer education and support
network. “It may only be a first step toward the development of more
effective and even safer agents for the prevention of this disease, but it
would further validate the concept of chemoprevention for men at risk of one
of the most common forms of cancer, thereby encouraging continued research
into newer and potentially better agents for the future.”
As prostate cancer continues to strike one in six American men, and with
African American men having an incidence rate up to 60% higher than white
men, it is important that patients and their physicians engage in a
meaningful conversation about prostate cancer, about individual risk for
this disease, and about the value of prevention, early detection, and
appropriate management.
Wendy Poage, president of the Prostate Conditions Education Council stated,
“I cannot over-emphasize the importance for men to engage in an ongoing
dialogue with their healthcare providers about their individual risk for
prostate cancer and the need for appropriate baseline and follow-up testing.
It could mean the difference between living with or dying from this
disease.”
About Prostate Cancer
Prostate cancer is the most prevalent form of cancer among American males.
Nearly 220,000 men will be diagnosed with prostate cancer in 2010, and about
32,000 will die from this disease. Risk factors for prostate cancer are
known to include race, family history, elevated PSA levels, positive
findings on a digital rectal examination, and selected pathological findings
on prior biopsies.
About Dutasteride
Dutasteride is a 5α-reductase inhibitor, already marketed in the USA under
the brand name Avodart. Dutasteride has previously been approved in the USA
and other countries around the world for the treatment of moderate-to-severe
symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged
prostate. When used in the management of BPH, dutasteride has been shown to
improve urinary tract symptoms, to reduce the risk of acute urinary
retention, and to lower risk for surgical intervention to resolve symptoms
of BPH.
Dutasteride, like all other prescription medicines, is known to be
associated with some common and some rare side effects. Common side effects
of dutasteride (occurring in less than 5% of patients) include impotence,
decreased libido, difficulty with ejaculation, and tenderness or enlargement
of the breast. Dutasteride is also known to trigger a rare allergic
reaction. Signs of this allergic reaction include a skin rash, hives, and
swelling of the eyelids, face, lips, arms or legs.
In the REDUCE trial, men receiving dutasteride had an increased incidence of
heart failure (30 events or 0.7 percent) compared to men receiving placebo
(16 events or 0.4 percent).
About the Prostate Cancer Roundtable
The Prostate Cancer Roundtable is a group of independent, not-for-profit
organizations which cooperate to foster the development of policies
supporting the prevention and early detection of clinically significant
prostate cancer, the effective treatment of men with this disease, and the
appropriate education of all men at risk for this disease.
###
The above statement has been issued on behalf of and endorsed by
American Urological Association Foundation
Sunday, November 14, 2010
Cancer Survivor Bob Whitesel on Provenge treatment
Commenter: Whitesel, Robert
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]
[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.
I wish to make three (3) points in support of my affirmative response to the question above:
[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.
3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.
Date: 07/29/2010
Comment:
Autologous cellular immunotherapy Is it "reasonable and necessary" under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act? My name is Robert Whitesel. [PHI Redacted]
[PHI Redacted] Autologous cellular immunotherapy seems more "reasonable" to me than other Medicare accepted prostate cancer therapies, e.g., radical prostatectomy and chemotherapy. To treat aggressive, advanced cancers, to be sure, it would seem to me at least as "necessary" as the aforementioned therapies already accepted as reasonable.
I wish to make three (3) points in support of my affirmative response to the question above:
[PHI Redacted]
2. It is important to minimize treatments with destructive side effects. Quality of life suffers and the patient's immune system may be weakened and left vulnerable to other diseases. This therapy has been designed to build on the immune- system-boosting-capability of GM-CSF (granulocyte macrophage-colony stimulating factor) agents and doesn't leave one's immune system compromised by the destructive effects of taxane-based chemotherapy agents.
3. Some way must be found to reduce the cost of this out- patient-administered therapy. Long-term costs could be reduced by treating the largest possible number of qualified patients early in their disease progression, thereby putting the cancer cells at least into dormancy and reducing or eliminating the subsequent need of today's similarly costly and less-effective treatments for these men.
Urologist Dr Mark Scholz on Provenge as Treatment
Dear CMS Reviewers,
As an oncologist who specializes in treating
prostate cancer patients, I was extremely pleased
when the U.S. Food and Drug Administration
approved Provenge for the treatment of
metastatic, castrate resistant prostate cancer as
it represents an important advancement not only
in the treatment of prostate cancer, but the
beginning of a new treatment paradigm for the
treatment of all cancers.
I have used Provenge in my practice and continue
to be impressed by the ease of administration
with the treatment, as well as the almost total
lack of side effects experienced by patients. As
someone who has worked with prostate cancer
patients for nearly 20 years, I am all too
familiar with the difficult issues that patients
sometimes face with other treatments. Provenge
marks a new chapter in how I am able to treat my
patients, one that offers an improved survival
benefit, as well as an extremely mild side effect
profile and treatment duration when compared to
other treatments, such as chemotherapy. The
limited toxicity is so critical in maintaining a
good quality of life in these elderly ,
testosterone deprived individuals.
In addition to my clinical work, I am also the co-
founder and executive director of the Prostate
Cancer Research Institute, a non-profit
educational and research institute the focuses on
disseminating state-of-the-art information about
the diagnosis, staging and treatment of prostate
cancer. Provenge’s availability provides
healthcare professionals, as well as the patients
we treat, with a long-awaited and much-needed
alternative therapy for one of the neediest
patient populations in the prostate cancer
community.
There is a great deal of excitement among the
prostate cancer community to have a new and
effective treatment in the form of an
immunotherapy. I firmly believe that CMS has a
duty to both patients and their healthcare
providers to fully reimburse Provenge for the
indication in which it was approved, ensuring
that patients who have long awaited a new
treatment option to help them in their battle
with prostate cancer will have access to it. I
ask you, as a physician and an advocate for the
prostate cancer community, please do not delay or
inhibit access to Provenge.
Mark Scholz, M.D.
Medical Director of Prostate Oncology
Specialists, Inc., Marina Del Ray, CA
Associate clinical professor at the University of
Southern California School of Medicine
Co-Founder and Executive Director of the Prostate
Cancer Research Institute
As an oncologist who specializes in treating
prostate cancer patients, I was extremely pleased
when the U.S. Food and Drug Administration
approved Provenge for the treatment of
metastatic, castrate resistant prostate cancer as
it represents an important advancement not only
in the treatment of prostate cancer, but the
beginning of a new treatment paradigm for the
treatment of all cancers.
I have used Provenge in my practice and continue
to be impressed by the ease of administration
with the treatment, as well as the almost total
lack of side effects experienced by patients. As
someone who has worked with prostate cancer
patients for nearly 20 years, I am all too
familiar with the difficult issues that patients
sometimes face with other treatments. Provenge
marks a new chapter in how I am able to treat my
patients, one that offers an improved survival
benefit, as well as an extremely mild side effect
profile and treatment duration when compared to
other treatments, such as chemotherapy. The
limited toxicity is so critical in maintaining a
good quality of life in these elderly ,
testosterone deprived individuals.
In addition to my clinical work, I am also the co-
founder and executive director of the Prostate
Cancer Research Institute, a non-profit
educational and research institute the focuses on
disseminating state-of-the-art information about
the diagnosis, staging and treatment of prostate
cancer. Provenge’s availability provides
healthcare professionals, as well as the patients
we treat, with a long-awaited and much-needed
alternative therapy for one of the neediest
patient populations in the prostate cancer
community.
There is a great deal of excitement among the
prostate cancer community to have a new and
effective treatment in the form of an
immunotherapy. I firmly believe that CMS has a
duty to both patients and their healthcare
providers to fully reimburse Provenge for the
indication in which it was approved, ensuring
that patients who have long awaited a new
treatment option to help them in their battle
with prostate cancer will have access to it. I
ask you, as a physician and an advocate for the
prostate cancer community, please do not delay or
inhibit access to Provenge.
Mark Scholz, M.D.
Medical Director of Prostate Oncology
Specialists, Inc., Marina Del Ray, CA
Associate clinical professor at the University of
Southern California School of Medicine
Co-Founder and Executive Director of the Prostate
Cancer Research Institute
Medical Phyicist Robert Baker to MEDCAC on Provenge
View Public Comment for Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (CAG-00422N)
Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer
I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!
Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.
Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.
The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!
Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.
This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.
In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!
Commenter: Baker, Robert
Title: Consultant, CEO
Organization: RJB Consulting
Date: 07/14/2010
Comment:
I am a Medical Physicist (Ph. D., licensed by the
American Board of Radiology), and have worked in
the medical field for more than 35 years. My role
always involves patients being treated with
radiation, e.g. from a linear accelerator treating
a cancer patient, or implanted radioactive seeds;
both of these techniques are often directed at
prostate cancer
I began my career in the early 1970’s, at the
University of California, San Francisco Medical
Center, (now a clinical trial center, with
researchers enthused about Provenge, and a very
long waiting list of patients!). Chemotherapy was
new and experimental then; Radiation Oncologists
began prescribing these new drugs (there were no
Medical Oncologists yet); doctors called them the
“telephone drugs”, because they had names like
Roche 7473. (These doctors also referred to them
as “poison”). Now we have enough of these drugs
to fill a phone book!
Then President Nixon declared the “War on
Cancer”. After several decades, and billions of
dollars had been spent on this “war”, I have heard
many of these same physicians say, in effect, “we
should just admit we have lost the war!” Cancer
incidence was up, not down, survival was not much
affected.
Since that time, we have had improvements in
treatment delivery involving radiation (IMRT,
Gamma Knife, Cyberknife, etc), but radiation’s
effect is explained statistically; radiation never
completely eliminates the tumor cells; it merely
reduces the tumor burden to the level that the
body’s own innate defenses can eradicate it.
The Holy Grail of Cancer research has always been
to activate the body’s natural defenses (the
immune system) to destroy the tumor. Provenge has
finally accomplished just this task, and as such,
it is the FIRST FDA approved product to do so!
Provenge has greatly reduced side effects,
compared to any and all chemotherapies. The
specific clinical trial leading to the final
approval of Provenge, involved patients with very
advanced stage prostate cancer, that had already
failed multiple other existing treatment regimens,
and in the majority of cases had already
metastasized; “compassionate use” allowed these
clinical trial patients in the Standard of Care
arm (Taxotere) to “cross over”, if they were
failing treatment under the standard treatment;
many did so (I believe the majority), and even
these were helped by Provenge, even though they
were provided the drug late, and with a preserved
(frozen) form of Provenge.
This is truly a remarkable accomplishment, a
dramatic result, and supporters of this product
believe (and there is evidence) that Provenge can
be even more effective when applied earlier and in
broader circumstances.
In summary: Provenge is a breakthrough,
disruptive, new, dramatic, life extending, quality
of life preserving, treatment, that should be made
available to all prostate cancer patients whose
doctors determine they will benefit!
Sunday, November 7, 2010
New Biomarker for Prostate Cancer
PROTEIN ARRAY ACCURATE
FOR PROSTATE CA
A panel of prostate cancer-derived
autoantibodies distinguished cancer
from benign prostatic hyperplasia and
healthy tissue with greater than 90%
accuracy, according to a preliminary
report from the 2010 American Association
for Cancer Research meeting.
The functional protein microarray had
similar accuracy for detecting cancer
(sensitivity) and for ruling it out when
used to evaluate noncancerous tissue
(specificity).
Prostate specific antigen (PSA) testing
also has a sensitivity of about 90% but a
specificity of less than 50%, John Anson,
PhD, said at a press briefing during
the American Association for Cancer
Research International Conference on
Molecular Diagnostics in Cancer Therapeutic
Development.
“What that means is there are lots of
potential false-positives,” said Anson, of
Oxford Gene Technology in the UK.
“What that translates to in clinical practice
is that a lot of men are going on for
unnecessary diagnostic procedures, such
as needle biopsies, and even radical
prostatectomy, which perhaps are not
required. Biomarker panels offer the
potential to significantly improve detection
of prostate cancer
FOR PROSTATE CA
A panel of prostate cancer-derived
autoantibodies distinguished cancer
from benign prostatic hyperplasia and
healthy tissue with greater than 90%
accuracy, according to a preliminary
report from the 2010 American Association
for Cancer Research meeting.
The functional protein microarray had
similar accuracy for detecting cancer
(sensitivity) and for ruling it out when
used to evaluate noncancerous tissue
(specificity).
Prostate specific antigen (PSA) testing
also has a sensitivity of about 90% but a
specificity of less than 50%, John Anson,
PhD, said at a press briefing during
the American Association for Cancer
Research International Conference on
Molecular Diagnostics in Cancer Therapeutic
Development.
“What that means is there are lots of
potential false-positives,” said Anson, of
Oxford Gene Technology in the UK.
“What that translates to in clinical practice
is that a lot of men are going on for
unnecessary diagnostic procedures, such
as needle biopsies, and even radical
prostatectomy, which perhaps are not
required. Biomarker panels offer the
potential to significantly improve detection
of prostate cancer
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