AP
Dendreon Gets Fast-Track for Provenge
Monday November 7, 10:37 am ET
Dendreon Gets Fast-Track Label From FDA for Its Provenge Prostate Cancer Treatment
SEATTLE (AP) -- Dendreon Corp. said Monday that the Food and Drug Administration granted "fast track" status to its experimental prostate cancer drug, a label that allows a company to submit data as it becomes available and includes scheduled meetings for FDA input.
The fast track designation -- for the treatment of metastatic, male hormone-independent prostate cancer in men who don't show symptoms -- is reserved for drugs that address an unmet medical need and can sometimes speed review.
Dendreon has said it will submit its application for the Provenge cancer drug using data from its two completed late-stage trials. The company's stock dipped in July over concerns that FDA might require a third study.
The company's shares rose 50 cents, or about 9 percent, to $6.08 in morning trading on the Nasdaq.
