As anticipated by many analysts, the FDA handed Dendreon an approvable letter for the company's prostate cancer drug Provenge, causing the company's shares to slide. The FDA requested more data on the drug's effectiveness, along with more information on the chemistry, manufacturing and controls of its application. Dendreon said it will meet with the FDA to better understand what efficacy data the agency is looking for. The approvable letter is no surprise: from the beginning, Dendreon's faced a challenge in persuading the FDA that data supporting a longer life for patients taking justified overlooking the fact the therapy missed its primary goal of delaying disease progression.
"Given our strong belief in the survival benefit and safety profile of Provenge, coupled with the positive outcome of the Advisory Committee meeting, we are disappointed that this decision will cause a delay in the availability of Provenge for patients who suffer from advanced prostate cancer," said Mitchell H. Gold, M.D., president and CEO of Dendreon. "We are committed to working closely with the FDA to resolve these questions in a timely and efficient manner to bring Provenge to patients with advanced prostate cancer who currently have few appealing treatment options."
- see Dendreon's release on the approvable letter
Dendreon shares slip as investors check enthusiasm. Report
Dendreon to pursue Provenge approval. Report
Dendreon plans to raise $59M to market Provenge. Report
Dendreon shares rising on Provenge speculation. Report