FDAnews Drug Daily Bulletin

A federal judge has dismissed two parts of a lawsuit filed by a nonprofit group to get the FDA to reverse a decision that delayed approval of Dendreon’s prostate cancer vaccine Provenge.

CareToLive, an advocacy group, sued the FDA after the agency requested more efficacy data for Provenge (sipuleucel-T) despite a positive vote from its Cellular, Tissue and Gene Therapies Advisory Committee, which voted 13–4 that Provenge was effective and 17–0 that it was safe.

In its suit, CareToLive alleges that the Center for Drug Evaluation and Research’s Office of Oncology Drug Products Director Richard Pazdur pressured committee members to deny due process for Provenge’s biologic license application (BLA). Pazdur also deliberately placed two oncologists he knew would vote against Provenge on the committee prior to the vote, the complaint says.

The FDA is still reviewing Provenge’s application and may ultimately approve it, which would render the plaintiff’s claims moot, U.S. District Court for the Southern District of Ohio Judge Gregory Frost said. CareToLive failed to support the claim that a complete response letter from the FDA constitutes final agency action.

Because the action is not final, the court could only issue a remand to the FDA to continue its review of Provenge’s BLA, which would not speed patients’ access to the drug, the judge said. The FDA’s complete response letter “at most, potentially prevents access to an unproven and speculative future benefit.”

The court order can be seen at caretolive.com/CTLorderonmotioncapacityclaims.pdf.