We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.
As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
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Sunday, July 31, 2011
Tuesday, July 26, 2011
Prostate Cancer Risks for Men inBreastCancerFamilies
THE "NEW" PROSTATE CANCER INFOLINKEntries RSS | Comments RSS Follow The "New" Prostate Cancer InfoLink news blog on TWITTER or FACEBOOK.
Copyright © 2008-11 Prostate Cancer International, Inc.Prostate cancer and prostate cancer-specific survival of men from breast cancer-prone families
Posted on July 26, 2011 by Sitemaster
i1 Votes
An Australian research team has used data from 148 men from 1,423 families identified through the Kathleen Cunningham Consortium for Research into Familial Breast Cancer (kConFab) to assess the risks associated with prostate cancer in males from breast cancer-prone families, and most particularly from those families in which the BRCA2 gene mutation is prevalent.
Although it is well understood that there is a strong association between the presence of the BRCA2 gene mutation and the risk for development of prostate cancer, the consequent clinical presentation of prostate caner in such men, and their treatment-related outcomes, have not previously been thoroughly characterized.
kConFab is a multi-center research consortium that identifies and studies families at high risk for breast cancer from across Australia and New Zealand. Thorne et al. were able to search the kConFab database to identify 148 male patients who met the following three criteria:
They had all been diagnosed with prostate cancer.
They were all confirmed as either a carrier or a non-carrier of a family-specific BRCA pathogenic mutation.
Comprehensive clinical and treatment data were available on all 148 men.
Detailed analysis of the clinical and familial data from these 148 male prostate cancer patients established the following:
The men all had high risk of disease progression, irrespective of mutation status.
Carriers of the BRCA2 mutation had an increased risk of overall and prostate cancer-specific mortality (hazard ratio [HR] = 4.5; P = 8.9 × 10-5) by comparison with non-carriers.
For both carriers and non-carriers of the BRCA2 mutation given first-line treatment with curative intent, long-term survival outcomes were relatively poor (when compared to the survival outcomes of men from non-breast cancer-prone families
Serum PSA readings taken prior to diagnosis in 90 percent of these men, after age adjustment, were above clinical significance.
Based on the D’Amico risk stratification criteria
77.5 percent of the carriers of the BRCA2 mutation had high-risk disease
58.7 percent of non-carriers also had high-risk disease.
BRCA2 mutation status was an independent prognostic indicator of overall survival.
Thorne et al. conclude that:
If diagnosed with prostate cancer, all men in breast cancer-prone families are at significant risk of developing an aggressive form of the disease.
This information should be made clear by genetic counselors and medical professionals in discussions about cancer risk with men in such families, whether the individual is a carrier or a non-carrier of a BRCA gene mutation.
Share this: Facebook
t
Copyright © 2008-11 Prostate Cancer International, Inc.Prostate cancer and prostate cancer-specific survival of men from breast cancer-prone families
Posted on July 26, 2011 by Sitemaster
i1 Votes
An Australian research team has used data from 148 men from 1,423 families identified through the Kathleen Cunningham Consortium for Research into Familial Breast Cancer (kConFab) to assess the risks associated with prostate cancer in males from breast cancer-prone families, and most particularly from those families in which the BRCA2 gene mutation is prevalent.
Although it is well understood that there is a strong association between the presence of the BRCA2 gene mutation and the risk for development of prostate cancer, the consequent clinical presentation of prostate caner in such men, and their treatment-related outcomes, have not previously been thoroughly characterized.
kConFab is a multi-center research consortium that identifies and studies families at high risk for breast cancer from across Australia and New Zealand. Thorne et al. were able to search the kConFab database to identify 148 male patients who met the following three criteria:
They had all been diagnosed with prostate cancer.
They were all confirmed as either a carrier or a non-carrier of a family-specific BRCA pathogenic mutation.
Comprehensive clinical and treatment data were available on all 148 men.
Detailed analysis of the clinical and familial data from these 148 male prostate cancer patients established the following:
The men all had high risk of disease progression, irrespective of mutation status.
Carriers of the BRCA2 mutation had an increased risk of overall and prostate cancer-specific mortality (hazard ratio [HR] = 4.5; P = 8.9 × 10-5) by comparison with non-carriers.
For both carriers and non-carriers of the BRCA2 mutation given first-line treatment with curative intent, long-term survival outcomes were relatively poor (when compared to the survival outcomes of men from non-breast cancer-prone families
Serum PSA readings taken prior to diagnosis in 90 percent of these men, after age adjustment, were above clinical significance.
Based on the D’Amico risk stratification criteria
77.5 percent of the carriers of the BRCA2 mutation had high-risk disease
58.7 percent of non-carriers also had high-risk disease.
BRCA2 mutation status was an independent prognostic indicator of overall survival.
Thorne et al. conclude that:
If diagnosed with prostate cancer, all men in breast cancer-prone families are at significant risk of developing an aggressive form of the disease.
This information should be made clear by genetic counselors and medical professionals in discussions about cancer risk with men in such families, whether the individual is a carrier or a non-carrier of a BRCA gene mutation.
Share this: Facebook
t
Monday, July 18, 2011
Support for Provenge, a Prostate Cancer Dug
Provenge, a Prostate Cancer Dug
CloseLinkedinDiggMySpacePermalinkTo the Editor:
We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.
As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
CloseLinkedinDiggMySpacePermalinkTo the Editor:
We at the Men’s Health Network, a member and the convener of the Prostate Cancer Roundtable, were dismayed by your July 7 editorial “Extremely Expensive Cancer Drugs,” which questioned whether a new prostate cancer treatment, Provenge, was worth the cost.
As noted, Provenge’s median survival is 4.1 months, meaning that half of patients live beyond that point — some far beyond. We have fought to make sure that innovative treatments like Provenge are within reach for all patients, regardless of ability to pay.
Late-stage prostate cancer was for many years a forgotten cancer. Thousands of men without access to life-extending treatment died prematurely. Now, because of innovative advancements, we have an arsenal of drugs and therapies that improve survival and quality of life, with more on the way.
Health care dollars being spent to extend the lives of men with prostate cancer are not a waste. Just ask the survivors and their spouses, partners and families.
SCOTT T. WILLIAMS
Washington, July 12, 2011
The writer is vice president of the Men’s Health Network.
Wednesday, July 13, 2011
American Cancer Society on PSA Screening
The American Cancer Society (ACS) recommends that men have a chance to make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risks, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information.
The discussion about screening should take place at age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.
This discussion should take place starting at age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).
This discussion should take place at age 40 for men at even higher risk (those with several first-degree relatives who had prostate cancer at an early age).
After this discussion, those men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening.
If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the patient’s general health preferences and values.
Men who choose to be tested who have a PSA of less than 2.5 ng/ml, may only need to be retested every 2 years.
Screening should be done yearly for men whose PSA level is 2.5 ng/ml or higher.
Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.
Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient's health, values, and preferences.
The discussion about screening should take place at age 50 for men who are at average risk of prostate cancer and are expected to live at least 10 more years.
This discussion should take place starting at age 45 for men at high risk of developing prostate cancer. This includes African Americans and men who have a first-degree relative (father, brother, or son) diagnosed with prostate cancer at an early age (younger than age 65).
This discussion should take place at age 40 for men at even higher risk (those with several first-degree relatives who had prostate cancer at an early age).
After this discussion, those men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as a part of screening.
If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the patient’s general health preferences and values.
Men who choose to be tested who have a PSA of less than 2.5 ng/ml, may only need to be retested every 2 years.
Screening should be done yearly for men whose PSA level is 2.5 ng/ml or higher.
Because prostate cancer grows slowly, those men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.
Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in the patient's health, values, and preferences.
Saturday, July 9, 2011
Mediterranean Diet Fundamentals
The Mediterranean diet has been shown to reduce the risk of death from both heart disease and cancer, lower the risk of developing type 2 diabetes, control weight, lower blood pressure and cholesterol levels, and even reduce the risk of Alzheimer’s disease. Convinced?
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Mediterranean Diet Fundamentals
The Mediterranean diet has been shown to reduce the risk of death from both heart disease and cancer, lower the risk of developing type 2 diabetes, control weight, lower blood pressure and cholesterol levels, and even reduce the risk of Alzheimer’s disease. Convinced?
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Here are the 11 foundations of the Mediterranean diet to help you get started:
Get lots of exercise
Don’t eat alone: share your meals with family and friends. Savor and enjoy your food and your company. Eat slowly
Enjoy generous amounts of fruits, vegetables, and legumes
Consume healthy fats such as monounsaturated fats (olive and canola oils) and omega-3 fatty acids
Use herbs and spices instead of salt to flavor foods
Eat small portions of nuts
Drink red wine, in moderation
Consume very little red meat (the traditional Mediterranean diet is practically vegetarian)
Eat shellfish or fish at least twice a week
Eat locally grown, seasonal foods and avoid processed foods
Practice portion control—small portions of high-quality food
Prostate Benefits of The Mediterranean Diet
A study published in the October 2009 issue of Maturitas noted that men and women who reported eating foods closest to the Mediterranean diet were about 10 to 20 percent less likely to die of heart disease, cancer, or any other cause. The Mediterranean diet was also associated with having a preventive effect on cancer and on reducing the prevalence of metabolic syndrome and obesity.
Data gathered from more than 10,000 cases showed that certain elements of a Mediterranean diet were associated with reduced cancer risk, including monounsaturated fats, fish (and omega-3 fatty acids), and whole grain foods, while frequent red meat and refined grain intake were directly related to some cancers. (Bosetti 2009)
University of Melbourne researchers looked at prostate cancer mortality among Greek men in Greece and those who had migrated to Australia and found that the migrants had retained their low risk for the disease and their diet. The researchers also noted that the Mediterranean diet is rich in foods that may protect against prostate cancer, including legumes, soy foods, and those high in vitamin E, lycopene, and selenium. (Itsiopoulos 2009)
In addition, studies have shown that men who follow the Mediterranean diet have a decreased risk of impotence/erectile dysfunction. Read more on ED and Diet
Filed Under
Malecare's Prostate Cancer Under (age) 50 program
Malecare's Prostate Cancer Under (age) 50 program began in late 2004 and Malecare's Advanced Prostate Cancer program began in late 2006. Today, we are asking you to tell us how we can make them better. Please email your suggestions and comments. We are asking in this free form way, as we know that each of you approaches your diagnosis, treatment and lives uniquely ... we want to fit your needs into our programs rather than create programs that you have to make an effort to fit into.
So, if you were diagnosed with prostate cancer before the age of 50, tell us what help is missing or what can be improved in your lives...in the services and support groups we offer....anything, everything....the sky and your imagination are your only limits. Family and friends are welcome to email their comments, too.
Same goes for those of you initially diagnosed with late stage prostate cancer, or were diagnosed with a recurrence of prostate cancer after a primary treatment.
I can tell you that we are revising the Advanced Prostate Cancer handbook that approx. 6,000 of you received. We're writing Version 2.0 and would welcome your critique of Version 1.x We're also planning many more teleconferences for you to attend.
All of our Malecare volunteer's have lots of work to do this summer, and we hope that you will help by taking just a few minutes to email your comments to me, Darryl, at darryl@malecare.org
P.S. Our advocacy efforts continue, with work focused on protecting the federal Prostate Cancer Research Program, building awareness with the second annual Men's Health Night on November 20 and trying to increase collaboration with our brother and sister cancer survivor nonprofits...more news about that, next month
So, if you were diagnosed with prostate cancer before the age of 50, tell us what help is missing or what can be improved in your lives...in the services and support groups we offer....anything, everything....the sky and your imagination are your only limits. Family and friends are welcome to email their comments, too.
Same goes for those of you initially diagnosed with late stage prostate cancer, or were diagnosed with a recurrence of prostate cancer after a primary treatment.
I can tell you that we are revising the Advanced Prostate Cancer handbook that approx. 6,000 of you received. We're writing Version 2.0 and would welcome your critique of Version 1.x We're also planning many more teleconferences for you to attend.
All of our Malecare volunteer's have lots of work to do this summer, and we hope that you will help by taking just a few minutes to email your comments to me, Darryl, at darryl@malecare.org
P.S. Our advocacy efforts continue, with work focused on protecting the federal Prostate Cancer Research Program, building awareness with the second annual Men's Health Night on November 20 and trying to increase collaboration with our brother and sister cancer survivor nonprofits...more news about that, next month
Wednesday, July 6, 2011
More Information on Provenge's FDA Approval
From: Dendreon Corporation Investor Relations
[mailto:newsdesk@broadcast.shareholder.com]
Sent: Thursday, June 30, 2011 4:52 PM
To: Riccio, Scott
Subject: Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
Dendreon Corporation
Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS
Announces National Coverage Decision, and Product Specific Q-Code Effective
-
SEATTLE, June 30, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced significant milestones that support broad availability for
on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
* The U.S. Food and Drug Administration (FDA) approved the Los Angeles
immunotherapy manufacturing facility on June 29, 2011. The facility includes
36 workstations, and Dendreon will bring these on in a staged approach.
* In addition, the Centers for Medicare and Medicaid Services (CMS)
issued a final National Coverage Decision (NCD) for PROVENGE on June 30,
2011, requiring Medicare contractors to cover the use of PROVENGE for
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. The NCD will standardize
coverage processes across the country for all Medicare patients with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer and provides the local Medicare Administrative
Contractors (MACs) specific criteria, consistent with the label, on how
PROVENGE should be covered.
* PROVENGE was issued a product specific Q-code effective July 1,
2011, which allows for electronic submission of claims and is expected to
accelerate time to payment for physicians.
* As part of this expanded access, Dendreon supports programs to
provide comprehensive assistance for eligible patients seeking access to
treatment with PROVENGE, including through grants to independent foundations
and establishment of a patient assistance program for uninsured patients.
Dendreon provides grants to independently run foundations providing
qualifying patients with financial assistance for co-pays, co-insurance, and
treatment-related travel costs.
"These significant achievements support broad access to PROVENGE, the
foundation of care for men with asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "The increased capacity
and positive National Coverage Decision by CMS in conjunction with the
patient assistance programs will ensure patients who may benefit from
treatment with PROVENGE have increased access to it."
For information about these programs, please visit www.provenge.com
PROVENGE Indication and Safety
PROVENGE was approved by the U.S. Food and Drug Administration in April 2010
as the first autologous cellular immunotherapy for the treatment of
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested
for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients
in four randomized clinical trials who underwent at least one leukapheresis
procedure. The most common adverse events (incidence greater than or equal
to 15%) reported in patients in the PROVENGE group are chills, fatigue,
fever, back pain, nausea, joint ache, and headache. Serious adverse events
reported in patients in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In
controlled clinical trials, severe (Grade 3) acute infusion reactions were
reported in 3.5% of patients in the PROVENGE group. Reactions included
chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness,
headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5
acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients, Dendreon will conduct a registry of
approximately 1,500 patients to further evaluate a small potential safety
signal of cerebrovascular events. In four randomized clinical trials of
PROVENGE in prostate cancer patients, cerebrovascular events were observed
in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in
the control group.
For more information on PROVENGE, please see the full Prescribing
Information at www.provenge.com
1-877-336-3736.
[mailto:newsdesk@broadcast.shareholder.com]
Sent: Thursday, June 30, 2011 4:52 PM
To: Riccio, Scott
Subject: Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
Dendreon Corporation
Dendreon Announces Increased Capacity and Significant Reimbursement
Decisions Supporting Broad Availability of PROVENGE
- FDA Approves Los Angeles Immunotherapy Manufacturing Facility, CMS
Announces National Coverage Decision, and Product Specific Q-Code Effective
-
SEATTLE, June 30, 2011 /PRNewswire/ -- Dendreon Corporation (Nasdaq: DNDN)
today announced significant milestones that support broad availability for
on-label use of PROVENGE® (sipuleucel-T), the first autologous cellular
immunotherapy for the treatment of asymptomatic or minimally symptomatic
metastatic castrate resistant (hormone refractory) prostate cancer (mCRPC).
* The U.S. Food and Drug Administration (FDA) approved the Los Angeles
immunotherapy manufacturing facility on June 29, 2011. The facility includes
36 workstations, and Dendreon will bring these on in a staged approach.
* In addition, the Centers for Medicare and Medicaid Services (CMS)
issued a final National Coverage Decision (NCD) for PROVENGE on June 30,
2011, requiring Medicare contractors to cover the use of PROVENGE for
treatment of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer. The NCD will standardize
coverage processes across the country for all Medicare patients with
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer and provides the local Medicare Administrative
Contractors (MACs) specific criteria, consistent with the label, on how
PROVENGE should be covered.
* PROVENGE was issued a product specific Q-code effective July 1,
2011, which allows for electronic submission of claims and is expected to
accelerate time to payment for physicians.
* As part of this expanded access, Dendreon supports programs to
provide comprehensive assistance for eligible patients seeking access to
treatment with PROVENGE, including through grants to independent foundations
and establishment of a patient assistance program for uninsured patients.
Dendreon provides grants to independently run foundations providing
qualifying patients with financial assistance for co-pays, co-insurance, and
treatment-related travel costs.
"These significant achievements support broad access to PROVENGE, the
foundation of care for men with asymptomatic or minimally symptomatic
metastatic castrate resistant prostate cancer," said Mitchell H. Gold, M.D.,
president and chief executive officer of Dendreon. "The increased capacity
and positive National Coverage Decision by CMS in conjunction with the
patient assistance programs will ensure patients who may benefit from
treatment with PROVENGE have increased access to it."
For information about these programs, please visit www.provenge.com
PROVENGE Indication and Safety
PROVENGE was approved by the U.S. Food and Drug Administration in April 2010
as the first autologous cellular immunotherapy for the treatment of
asymptomatic or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested
for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients
in four randomized clinical trials who underwent at least one leukapheresis
procedure. The most common adverse events (incidence greater than or equal
to 15%) reported in patients in the PROVENGE group are chills, fatigue,
fever, back pain, nausea, joint ache, and headache. Serious adverse events
reported in patients in the PROVENGE group include acute infusion reactions
(occurring within 1 day of infusion) and cerebrovascular events. In
controlled clinical trials, severe (Grade 3) acute infusion reactions were
reported in 3.5% of patients in the PROVENGE group. Reactions included
chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness,
headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5
acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's
ongoing commitment to patients, Dendreon will conduct a registry of
approximately 1,500 patients to further evaluate a small potential safety
signal of cerebrovascular events. In four randomized clinical trials of
PROVENGE in prostate cancer patients, cerebrovascular events were observed
in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in
the control group.
For more information on PROVENGE, please see the full Prescribing
Information at www.provenge.com
1-877-336-3736.
Medicare now covers first FDA-approved immunotherapy for PCa treatment
Medicare now covers first FDA-approved immunotherapy for prostate cancer treatment
Medicare patients with metastatic prostate cancer can get a first-of-its kind treatment just approved by the Food and Drug Administration, under a final coverage decision issued today by the Centers for Medicare & Medicaid Services (CMS).
Autologous cellular immunotherapy, known clinically as sipuleucel-T, is marketed in the United States as Provenge, for treating some forms of prostate cancer in seriously ill patients. Today’s decision is effective immediately.
Provenge activates a patient’s own immune system to defend him against prostate cancer. The treatment consists of a multi-day regimen in which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells. After the patient’s cells are treated, the patient receives his own cells back into his body in order to stimulate his immune system to fight the prostate cancer. This regimen is repeated over several weeks for a total of three treatments.
“We are optimistic that innovative str ategies may improve the experience of care for our beneficiaries who have cancer,” said CMS Administrator Donald M. Berwick, M.D. “CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes.”
Prostate cancer is the most common non-skin cancer in men in the United States. The cancer forms in the prostate, a gland in the male reproductive system, which can spread to other parts of the body and threaten life. In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and an estimated 27,360 men died. According to the National Cancer Institute, prostate cancer is most commmonly a cancer of older men, with most men diagnosed after 65 and the median age at diagnosis of 72.
CMS internally initiated the national coverage determination process for Provenge for multiple reasons, including: variations in local coverage; questions about the appropriate benefit category for Provenge; and inquiries from Congress. There was no prior NCD on this technology, and local contractors were generally making case by case determinations.
CMS convened the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a group of nationally recognized independent medical and scientific experts, on November 17, 2010 to make recommendations about the evidence. The MEDCAC votes supported coverage of Provenge for the FDA labeled indication and did not support coverage for unlabeled uses.
Today’s coverage decision includes coverage of Provenge for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
More information for patients and health professionals about FDA’s approved uses of Prpvemge is online at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210037.htm.
“CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label,” said Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Similar to other tr eatment decisions, individual patients should discuss the risks and benefits with their physician to make an individual decision.”
The final coverage decision is available on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Autologous%20Cellular% 20Immunotherapy%20Treatment%20of%20Metastatic%20Prostate%20Cancer&bc=ACAAAAAAIAAA&NCAId=247&.
Medicare patients with metastatic prostate cancer can get a first-of-its kind treatment just approved by the Food and Drug Administration, under a final coverage decision issued today by the Centers for Medicare & Medicaid Services (CMS).
Autologous cellular immunotherapy, known clinically as sipuleucel-T, is marketed in the United States as Provenge, for treating some forms of prostate cancer in seriously ill patients. Today’s decision is effective immediately.
Provenge activates a patient’s own immune system to defend him against prostate cancer. The treatment consists of a multi-day regimen in which the patient’s white blood cells are collected and exposed to proteins that direct the white blood cells to fight prostate cancer cells. After the patient’s cells are treated, the patient receives his own cells back into his body in order to stimulate his immune system to fight the prostate cancer. This regimen is repeated over several weeks for a total of three treatments.
“We are optimistic that innovative str ategies may improve the experience of care for our beneficiaries who have cancer,” said CMS Administrator Donald M. Berwick, M.D. “CMS is dedicated to assuring that these patients can seek the treatments they need in accordance with their wishes.”
Prostate cancer is the most common non-skin cancer in men in the United States. The cancer forms in the prostate, a gland in the male reproductive system, which can spread to other parts of the body and threaten life. In 2009, an estimated 192,280 new cases of prostate cancer were diagnosed and an estimated 27,360 men died. According to the National Cancer Institute, prostate cancer is most commmonly a cancer of older men, with most men diagnosed after 65 and the median age at diagnosis of 72.
CMS internally initiated the national coverage determination process for Provenge for multiple reasons, including: variations in local coverage; questions about the appropriate benefit category for Provenge; and inquiries from Congress. There was no prior NCD on this technology, and local contractors were generally making case by case determinations.
CMS convened the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), a group of nationally recognized independent medical and scientific experts, on November 17, 2010 to make recommendations about the evidence. The MEDCAC votes supported coverage of Provenge for the FDA labeled indication and did not support coverage for unlabeled uses.
Today’s coverage decision includes coverage of Provenge for the uses approved by the FDA: for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
More information for patients and health professionals about FDA’s approved uses of Prpvemge is online at http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210037.htm.
“CMS is covering Provenge nationally only for those indications supported by evidence and consistent with the FDA label,” said Patrick Conway, MD, MSc, CMS Chief Medical Officer and Director of the Agency’s Office of Clinical Standards & Quality. “Similar to other tr eatment decisions, individual patients should discuss the risks and benefits with their physician to make an individual decision.”
The final coverage decision is available on the CMS website at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?&NcaName=Autologous%20Cellular% 20Immunotherapy%20Treatment%20of%20Metastatic%20Prostate%20Cancer&bc=ACAAAAAAIAAA&NCAId=247&.
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