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.

3 Responses

  1. I’m looking foward Provenge’s approval. My father needs it.

    Thank you!

  2. Based on my research there is still the possibility of Provenge going to a panel.

  3. Dear Mr. Favus:

    It is certainly true that, in theory, FDA could convene another advisory board meeting to address the application to approve Provenge. However, frankly, since they are required to rule on this approve within the next 14 days, it would seem extraordinary to me that, if they had any intention of convening such a panel, they had not announced it by now.

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