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US court denies Provenge supporters' appeal

This article was originally published in Scrip

Executive Summary

A US federal appeals court has declined to reinstate a patient advocacy group's lawsuit challenging the FDA's refusal to approval Dendreon's novel prostate cancer vaccine Provenge (sipuleucel-T). The court affirmed a November ruling by an Ohio federal judge, who said Care to Live's claims against three federal officials and an FDA advisory panel member who voted against recommending Provenge for approval were not ripe for adjudication because the agency has not taken final action on the BLA. In May 2007 the FDAissued a "complete response" letter to Dendreon requesting additional data to support the vaccine's efficacy. Care to Live – which represents cancer patients, families, doctors, investors and advocates – sued the agency, alleging that political infighting impacted the agency's decisions. Care to Live's website said the group will petition the Supreme Court for review.

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