FDA Approves the First Immunotherapy, Provenge, for Metastatic Prostate Cancer

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For men with advanced metastatic prostate cancer that did not respond to hormone therapy, there is a new hope for improved survival.  FDA has approved an immunotherapy sipuleucel-T (Provenge, Dendreon), for the treatment of asymptomatic or minimally symptomatic metastatic, castration-resistant prostate cancer (mCRPC). 

The new treatment is an immunotherapy that is made from the patient’s own white blood cells and stimulates a patient’s immune system to respond against the cancer. 

In the phase 3 IMPACT study, men who had been treated with Provenge (n=341) had a median survival of 25.8 months, compared with median survival of 21.8 months among men who had been treated with placebo (n=171).

In other words, the new therapy offered a 4.1 month median survival advantage and a 24.1% reduction in the risk of death (hazard ratio, 0.759; P = 0.017) when compared with placebo.

The most common adverse reactions reported with the new products are chills, fatigue, fever, back pain, nausea, joint ache, and headache.  Majority of adverse reactions were mild or moderate.  Serious adverse reactions which were reported in approximately one quarter of the patients included acute infusions and stroke.

Cerebrovascular events, included hemorrhagic and ischemic strokes, were observed in 3.5% of patients in the Provenge, compared with 2.6% of patients in the placebo control group. 

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