Activists Push for Prostate Cancer Drug Approval
About 100 activists from 19 organizations on Monday rallied in Washington, D.C., to urge FDA to approve Seattle-based Dendreon's prostate cancer drug Provenge, the Philadelphia Inquirer reports (McCullough, Philadelphia Inquirer, 6/5).
FDA in May withheld approval of Provenge and instead issued an "approvable" letter, a move that could delay approval of the drug for at least two years. Provenge is a so-called cancer vaccine, part of an experimental class of treatments designed to use the body's white blood cells to attack tumors.
An FDA advisory panel in March recommended that the agency approve Provenge, voting 17-0 that the drug was "reasonably safe" and 13-4 in support of its efficacy. However, neither of the two late-stage studies that Dendreon submitted to FDA reached their stated endpoints.
The studies' results failed to show that Provenge slowed tumor growth, which was Dendreon's original intention. An unplanned analysis performed on a 127-patient study that failed to meet its primary goal suggested that patients taking the drug lived 4.5 months longer than those who were not on the drug.
FDA in its letter asked for additional clinical data to support Dendreon's claim that the drug is effective. FDA also is seeking additional information on the drug's chemistry, manufacturing and controls section of the approval application (California Healthline, 5/10).
After the rally, six activists met with FDA Commissioner Andrew von Eschenbach to discuss the drug.
Thomas Farrington, founder of the Prostate Health Education Network, said, "You're talking a minimum of two more years. Since prostate cancer kills 27,000 men a year, you're talking 54,000 deaths."
In related news, some prostate cancer treatment activists have "raised questions" about two advisory board members who voted against FDA approval of Provenge.
Maha Hussain of the University of Michigan and Howard Scher of Memorial Sloan-Kettering Cancer Center in New York both were granted conflict-of-interest waivers for their work on the committee and have been members of an FDA advisory committee that evaluates conventional cancer drugs.
Both members wrote complaint letters to top FDA officials about the committee's recommendation for approval, noting that the recommendation seemed to lower the standards of proof set by the FDA division that reviews conventional cancer drugs.
Ed Gorkes, a prostate cancer treatment advocate, said, "Their role is to give advice. Why are they so adamantly against this? We feel there is infighting among divisions of the FDA" (Philadelphia Inquirer, 6/5).
Christine Hickey, a spokesperson for Memorial Sloan-Kettering, said on Monday that Scher and Hussain have received threatening e-mails in recent weeks because of their opposition to the approval of Provenge (Timmerman, Bloomberg/Seattle Times, 6/5).