FDA is not satisfied with product’s efficacy data.

Dendreon has lost over half its value as the FDA has delayed approval of its only product. The agency has requested additional clinical data in support of Provenge’s efficacy in treating prostate cancer.

Dendreon filed a BLA for this immunotherapy for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer. On March 29, FDA’s Advisory Committee sanctioned the approval of this product. It voted 17 to 0 in favor of safety and 13 to 4 in favor of efficacy.

With the Advisory Committee’s green light, Dendreon saw its share soar overnight by nearly 148% to reach $12.93 by the end of trading on March 30. Today, however, the company shed over 50% of its value to open at $7.2. While this price represents about $2 more than what is was before Provenge received an okay from the advisory committee, the loss is significant as the company reached a peak of $23.58.

“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,” says Mitchell H. Gold, M.D., president and CEO of Dendreon.

If approved, Provenge will become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer.

The company reports that it is seeking a clarification from the FDA as to the nature of the data that is being requested. The FDA also asked for additional information with respect to the chemistry, manufacturing, and controls section of the BLA, which the company believes it can supply to the FDA in a timely manner.

“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,” adds Dr. Gold.

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