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A videotaped expert commentary by Dr. Johann de Bono on the Medscape Oncology web site (with transcript) discusses four therapies (three now approved in the USA) that have recently demonstrated a survival benefit in the treatment of metastatic, castration-resistant prostate cancer.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abiraterone acetate, cabazitaxel, radium-223, sipuleucel-T | Leave a Comment »
The Centers for Medicare and Medicaid Services (CMS) proposed yesterday that there is sufficient and adequate evidence to conclude that the use of autologous cellular immunotherapy treatment — sipuleucel-T (Provenge®) – improves health outcomes for Medicare beneficiaries
Filed under: Management, Treatment | Tagged: CMS, coverage, Medicare, Provenge, sipuleucel-T | Leave a Comment »
Dendreon’s production ramp-up for sipuleucel-T (Provenge®) is on track, the company says, with manufacturing expected to be up to full speed by year’s end. All three US-based manufacturing plants will be shipping by then, and treatment with Provenge should be available at hundreds of more locations, according to a Reuters report last week.
Filed under: Living with Prostate Cancer, Management | Tagged: access, Provenge, sipuleucel-T | Leave a Comment »
Physicians and researchers on a panel advising the Centers for Medicare & Medicaid Services (CMS) gave Provenge® a favorable vote at a “National Coverage Analysis” hearing yesterday in Washington, DC. You could almost hear the world of prostate cancer survivors, their physicians, Dendreon investors, and other drug development companies breathe a sigh of relief!
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: coverage, Medicare, Provenge, sipuleucel-T | 2 Comments »
Yesterday evening, the Centers for Medicare and Medicaid Services (CMS) announced that it was opening a “national coverage analysis to determine whether or not autologous cellular immunotherapy [for prostate cancer with sipuleucel-T/Provenge] is reasonable and necessary.”
Filed under: Management | Tagged: coverage, Medicaid, Medicare, Provenge, sipuleucel-T | 3 Comments »
According to a report on Bloomberg Businessweek earlier today, “rationing” of sipuleucel-T (Provenge), the new cellular immunotherapeutic agent approved for treatment of metastatic, castration-resistant prostate cancer, has already become evident.
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: capacity, Provenge, sipuleucel-T | Leave a Comment »
The National Comprehensive Cancer Network has updated its prostate cancer management guidelines to give a category 1 recommendation for clinical use of sipuleucel-T (Provenge) in the treatment of selected patients.
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: guidelines, NCCN, Provenge, sipuleucel-T | Leave a Comment »
There has been a lot of speculation as to what Dendreon would charge for a course of treatment with sipuleucel-T (Provenge). For 2 years, The “New” Prostate Cancer InfoLink has been telling readers that we expected this price to be not less than $75,000.
Filed under: Management, Treatment | Tagged: price, Provenge, sipuleucel-T | 5 Comments »
The US Food and Drug Administration has just announced that sipuleucel-T (Provenge) is approved for the treatment of patients with “asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.” Click here to see a copy of the FDA’s media release.
Filed under: Management, Treatment | Tagged: Provenge, sipuleucel-T | 1 Comment »
There has been a flurry of media stories as the “drop dead date” for a decision about approval of sipuleucel-T (Provenge) gets closer and closer.
Filed under: Drugs in development, Management, Treatment | Tagged: media, Provenge, sipuleucel-T | 4 Comments »
This is the week that the US FDA is expected to announce approval of the first “cancer vaccine” in the USA — sipuleucel-T (Provenge) for the treatment of hormone-refractory prostate cancer. This is a big deal for all sorts of reasons. There was an interesting article in Saturday’s Seattle Times on cancer vaccines in general [...]
Filed under: Drugs in development | Tagged: Provenge, sipuleucel-T | Comments Off
The “New” Prostate Cancer InfoLink stated a while ago that the FDA would not convene a second advisory committee meeting to discuss the results of the IMPACT trial.
Filed under: Drugs in development, Management, Treatment | Tagged: Provenge, sipuleucel-T | Leave a Comment »
The signals from Dendreon in September last year were that it would take the company until at least the end of 2011 to be able to “ramp up” to full manufacturing capacity for its prostate cancer immunotherapeutic agent, sipuleucel-T (Provenge), even if the FDA does approve this product in May or June of 2010 — [...]
Filed under: Drugs in development | Tagged: Dendreon, Provenge, sipuleucel-T | Leave a Comment »
According to a Reuters report this morning, the U.S. Food and Drug Administration has advised Dendreon that the company can expect a ruling on the approval of sipuleucel-T (Provenge), the company’s investigational immunotherapeutic agent for the treatment of hormone-refractory prostate cancer, on or before May 1, 2010.
Filed under: Drugs in development | Tagged: Provenge, sipuleucel-T | 3 Comments »
Earlier this year, Dendreon stated that the company expected to file a revised Biologics License Application (BLA) for sipuleucel-T (Provenge) by mid-November. The company reported today that filing of the revised BLA is now complete.
Filed under: Drugs in development, Uncategorized | Tagged: Provenge, sipuleucel-T | Leave a Comment »
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