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news.Biotech company Dendreon said that it has received an approvable letter from the FDA requesting further information on its hormone refractory prostate cancer vaccine Provenge.
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The FDA has asked for additional clinical data in support of the efficacy claim for the drug made by Seattle-based Dendreon, which is seeking a clarification as to the nature of the data requested. The FDA has also requested additional information with respect to the chemistry, manufacturing and controls section of the license application, which the company believes it can supply to the FDA.
Provenge is the first in a new class of active cellular immunotherapies that are uniquely designed to stimulate a patient’s own immune system. Dendreon’s biologics license application was based on a phase III study that showed that the group who received Provenge had a median survival time 4.5 months longer than the median survival seen in the group that had been assigned to receive placebo.
An advisory committee to the FDA voted 17 to 0 in favor of the safety of Provenge and 13 to 4 in favor of the efficacy of the drug.
Mitchell Gold, president and CEO of Dendreon, said: “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.”
Dendreon said that it would work with the FDA to resolve the issues.