A Look Inside the Provenge Decision: Who's In Charge at FDA?
This article was originally published in RPM Report
Executive Summary
A lawsuit filed by the non-profit group CareToLive charges that political infighting at FDA led the agency to reject Dendreon’s application for the therapeutic prostate cancer vaccine Provenge. The result, the suit claims, was a "successful coup d'etat" on the part of one senior FDA official and a failure to act decisively by his superioirs. The message, however, is broader: FDA and its staff can expect scathing, and now personal, attacks from all sides for safety and efficay decisions; with charges they are too accepting of safety issues or too demanding on efficacy.
You may also be interested in...
Cell Genesys/Takeda: Not Quite Validation for Cell Therapy
After enduring years of investor and partner skepticism, cell therapy has finally gotten what should be its validating deal: Cell Genesys's $50-million-upfront worldwide alliance with Takeda for Phase III GVAX prostate. But none of the companies who discussed licensing the product focused on the fact that it is a cellular therapy , regarding it as a prostate cancer treatment that happens to be a cellular therapy. Until GVAX delivers definitive and positive Phase III data, other cell therapy companies (like Dendreon and Antigenics) shouldn't get their partnering hopes up.
The Provenge Precedent
Dendreon's therapeutic cancer vaccine Provenge is the first of its kind to make it to an FDA advisory committee. The committee gave the novel agent a thumbs up. But FDA may disagree and turn away the prostate cancer vaccine until there is more conclusive data of its safety and effectiveness. How much does Dendreon stand to lose?
Nothing Random About It: The State of Cancer Drug Development at FDA
FDA is getting tougher on cancer drug approvals. But stakeholders on all sides-industry, regulators, and patient groups-say that's probably a good thing. Under the leadership of Richard Pazdur, MD, the controversial director of FDA's newly formed Office of Oncology Drug Products, the agency is raising the bar for getting cancer drugs on the market.