Pharmas Market with Mike Huckman

FDA Turns Over Dendreon Documents

When I got back from the Pfizer analyst meeting in New York City this afternoon, I found a treasure trove of PDF documents in one of my inboxes from a couple of Dendreon /Provenge proponents from their Freedom of Information Act request to the Food and Drug Administration.

At first, the FDA said it couldn't find any communications regarding the deliberations over whether to approve the prostate cancer drug.

In a response to the lawyer who filed the request the agency wrote on January 24 of this year that, "After a diligent search, this office has not located any responsive records." But apparently the FDA later discovered that wasn't the case. In a similar letter dated February 26 from the same "Freedom of Information Specialist" at the FDA it states, "...records were located in the Immediate Office of the Commissioner."

Here's what they found:

Most notable to those who are following the Dendreon / Provenge saga are the letters sent to FDA Commissioner Dr. Andrew von Eschenbach by the two influential FDA Advisory Committee members who were among the four panelists who voted against recommending approval of the drug. A congressional committee recently decided not to hold a hearing or launch an investigation into allegations of ethical violations and conflicts of interest against the two doctors.

On April 5 last year, Dr. Howard Scher wrote, "...the (clinical trial) results do not support an approval recommendation." And he argued against the precedent Provenge approval might set: "It also opens the door to the premature approval of drugs based on inconclusive data." His correspondence does not have any kind of letterhead.

But the communication from Dr. Maha Hussein was sent on University of Michigan Health System letterhead. Also last April, she wrote, "...this particular agent (Provenge) did not even meet criteria for its primary endpoint (clinical trial goal)."

Dr. Hussein advocated that the agency wait until an ongoing, larger clinical trial is finished before making a decision. "These questions (about safety and efficacy) will never be answered if the decision regarding this agent is not deferred at this time until all patients are accrued and data are mature," she wrote.

Dendreon says interim results of that study should be available in the second half of this year. If they're robust enough, the company says the FDA has indicated it might approve Provenge based on that early data. If not, the company, prostate cancer patients and the investment community will have to wait another year or two for the full results to come in.

Questions?  Comments?