Pressure for Provenge Approval

A prostate cancer patient group files suit, demanding an FDA green light of Dendreon's vaccine. Investors are on board, too

A group representing both prostate cancer patients and disgruntled investors is suing the Food & Drug Administration's commissioner and others involved in the agency's unexpected decision to disapprove a proposed vaccine called Provenge.

The lawsuit, filed July 30 in an Ohio federal court by, marks the latest salvo in an acrimonious campaign to gain access to the Dendreon (DNDN) vaccine after the FDA concluded in May that existing data did not warrant approval. New Jersey-based nonprofit Care To Live, started solely to lobby for Provenge, represents not only prostate cancer patients and their families, but Dendreon investors who saw their shares drop more than 60% within a day after the FDA's May 9 decision.

Recommended, but Not Approved

The FDA's move surprised some observers because an advisory panel made up of outside experts voted in March to recommend the drug's approval by a 13-to-4 margin. The panel also unanimously agreed that Provenge was safe. The agency usually follows the advice of its advisory panels, but this is a complicated situation: Provenge is the first drug to come before the FDA that would prompt the body's own immune system to fight tumors.

Although many scientists say such vaccines hold great promise, none have yet shown unequivocal proof that they're effective. Provenge, for example, did not shrink prostate tumors, the primary goal of its clinical trial. However, patients on the drug did live an average of four-and-a-half months longer than those on the standard treatment, adding what's considered a significant amount of time for very sick patients. But Dendreon's small clinical trial was not designed to measure survival, and the FDA rarely gives its approval under such circumstances. Dendreon is hoping to win approval after submitting the results of a larger trial that is designed to measure survival, but that data likely won't be available until 2010.

Conflicts of Interest?

The only treatment currently available for advanced prostate cancer, a disease expected to kill 30,000 men in the U.S. this year, is so toxic that many patients refuse it. Consequently, many were hopeful that the FDA would have O.K.'d Provenge by now. The delay has infuriated many patient advocates and investors, who have responded by lobbying Congress, holding rallies, taking out newspaper ads, and accusing the dissenting members of the advisory committee of conflicts of interest.

The lawsuit steps those efforts up a notch, naming three high-ranking federal officials: Dr. Andrew von Eschenbach, FDA Commissioner; Michael Leavitt, Secretary of the Health and Human Services Dept.; and Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products. The suit also targets Dr. Howard Scher, one of the four members of the FDA advisory panel to vote against recommending Provenge for approval. Scher, a prominent prostate cancer specialist at Memorial Sloan-Kettering Cancer Center in New York, has drawn so much ire that he had bodyguards protect him at a recent oncology meeting.

The Care To Live suit follows a more sweeping action taken by another patient advocacy group, the Abigail Alliance for Better Access to Developmental Drugs, which is suing for broader access to experimental drugs (see, 7/25/07, "Dying Patients Fight the FDA"). That lawsuit is currently being considered by the federal circuit court in Washington, D.C. If the Abigail Alliance prevails, it could establish a constitutional right to experimental drugs.

Care To Live describes itself as a nonprofit association of prostate cancer patients, families, doctors, investors, and patient advocates. The group and its lawyer did not respond to requests for an interview, but the lawsuit requests that the FDA be enjoined from denying marketing approval for Provenge. The group also wants the agency to declare that its failure to approve Provenge was due to improper actions taken by Scher and Pazdur. The FDA does not comment on pending litigation and Sloan-Kettering declined to comment.

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