Pharma Blog Watch

Possible Provenge Outcomes (Pharma's Cutting Edge)
In his blog, Fred Cohen discusses last week's decision by an FDA advisory committee to grant a positive opinion for approval of Dendreon's Provenge, an active immunotherapy for advanced hormone-refractory prostate cancer (HRPC).

"I think FDA will use common sense and approve Dendreon's therapy prior to completion of the ongoing 500-patient Phase IIIb trial, which is now roughly 80 percent enrolled and is expected to report in 2010," he writes, adding that "the drug seems safe and is reasonably well-tolerated. If there's a decent chance based on the results of one trial and an integrated analysis of efficacy that it will prolong survival why not approve it."

"The less good news is that treatment with Sipuleucel-T won't cure men with HRPC, prevent their tumors from growing or their pain from returning or return them to the workforce," he continues. "It's also going to cost a pretty penny."

"On the not-so-obvious front, should Sipuleucel-T become widely adopted and viewed as a standard of care that cannot be denied to patients with HRPC, it will make it more difficult for other drugs aimed at HRPC to be tested and approved."