Provenge wins favorable vote at CMS hearing

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! … READ MORE …

Fears that Medicare might not cover Provenge unfounded

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.” … READ MORE …

Limited production capacity for sipuleucel-T starts to hit patients, centers

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. … READ MORE …

NCCN gives strong endorsement for sipuleucel-T

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. … READ MORE …

Cost of Provenge set at $93,000 for a course of treatment

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. … READ MORE …

FDA approves Provenge

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. … READ MORE …

Media highly focused on expected Provenge approval

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. … READ MORE …

It’s crunch week for Provenge

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 and Provenge in particular.

No new FDA advisory committee meeting for Provenge

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. … READ MORE …

Supply and demand — Dendreon accelerates development of manufacturing capacity for Provenge

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 — which is what most people are currently expecting. … READ MORE …

FDA to rule on approval of Provenge by May 2010

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.

Dendreon files revised BLA for Provenge

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. … READ MORE …

When will Provenge get approved?

According to a media release issued yesterday by Dendreon, the company now expects to submit a revised New Drug Application for sipuleucel-T (Provenge) to the US Food and Drug Administration (FDA) in November this year. … READ MORE …

Prostate cancer news reports: Saturday, July 25, 2009

Today’s news reports address items on:

  • The burden of prostate cancer in Canada
  • Pelvic lymph node dissection and RALP
  • Data from early trials of sipuleucel-T in advanced prostate cancer
  • Implementation of osteoporosis screening guidelines in prostate cancer patients … READ MORE …

The IMPACT trial results: Tuesday April 27, 2009

OK … so here are the results we have all been waiting for for the past few weeks — the data from the IMPACT trial comparing the survival of patients treated with three doses of sipuleucel-T (Provenge) to placebo in men with androgen-independent prostate cancer. … READ MORE …