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.

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

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.

Stop press … Dendreon Provenge conference call

According to a media release from Dendreon earlier this evening, there will be a conference call at 9 am EST/6 am PT tomorrow morning (Tuesday, April 14) at which the company will “review the outcome of the FINAL analysis of its IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B) clinical trial of PROVENGE® [...]

What’s new with Provenge?

The “New” Prostate Cancer InfoLink has seen a couple of statements from members of the financial community in the last few days that could mislead the unwary into believing that Dendreon’s investigational immunotherapeutic agent, sipuleucel-T (Provenge), has already demonstrated a statistically significant survival benefit in its most recent Phase III clinical trial (the IMPACT trial)

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