Dendreon Corp. has received great news from the FDA about their pending application for the approval of Provenge.
NEW YORK (Dow Jones)–Dendreon Corp. (DNDN) Thursday said the Food and Drug Administration would accept interim trial data to meet the regulator’s request for additional information on the prostate cancer drug Provenge, sending the company’s shares sharply higher.
The surge in the Seattle company’s stock price reflects investors’ optimism that the cancer treatment – for which some project worldwide sales of more than $1 billion – may reach the market before final data is expected to be released in 2010.
“The FDA indicated that either a positive interim or final analysis of survival…would address their request for the submission of additional clinical data in support of our efficacy claim,” Chief Executive Mitchell H. Gold said in a press release. He added that the company expects to finish enrollment in the IMPACT study this year and sees interim survival results next year.
Shares of Dendreon were recently up $2.83, or 42%, at $9.57, with more than double the average daily volume of shares traded. Shares traded as much as 93% higher earlier Thursday.
Provenge is the first so-called active cellular immunotherapy drug, which tries to fight cancer by harnessing the body’s immune system. Current treatments attack the cancer cells directly.
Earlier this month, the FDA requested more clinical to support the effectiveness of the drug, which sent Dendreon shares plunging 60%. That followed an FDA panel recommendation in March after which the company’s stock price more than doubled.
At the time of the March meeting, nearly 33% of Dendreon’s float was sold short, as many doubted the treatment’s chances for approval. That number has since risen to 51% based on the latest figures available, which are through May 15, according to FactSet Research.
Assuming that the interim trial data holds up and does show that Provenge provides a statistically significant increase in survival rate, Provenge could be approved without the completion of the full pending trial. This would cut a full two years off the time we would have to wait to have Provenge available!
I believe that this flexibility on the part of the FDA is directly related to the pressure that has been placed on the agency. Patient advocates and physicians have joined in unprecedented numbers to urge that the FDA to reconsider its most recent decision delaying Provengeâ€™s approval. Malecare has gathered over 3,500 signatures on an Action letter to the FDA and there are currently plans for a rally in Washington and Chicago. Never before has the prostate cancer community gathered, with one voice, to insist that the number of drugs and treatments available for prostate cancer is increased.
It is my personal belief that the FDA has compromised as much as they can. I think it is now incumbent on our community to turn to Dendreon, and in one strong voice, insist that they reverse their prior decision not to support a Compassionate Use Program. PROVENGE NOW should mean NOW, with a Compassionate Use Program.
Joel T Nowak, MA, MSW