Pfizer's Medivation Receives FDA Approval For Prostate Cancer Drug XTANDI

Investors of Pfizer Inc. PFE failed to boost the sentiments after the company disclosed that its sNDA for prostate cancer drug XTANDI was granted approval by the FDA.

The company applied sNDA to upgrade the product labeling for capsules of XTANDI to add new clinical data compared to bicalutamide from the trial of TERRAIN. The drug firm indicated that the trial demonstrated radiographic progression-free survival (rPFS) enhancement in patients.

Pfizer's Medivation interim chief medical officer, Mohammad Hirmand, commented, "We are pleased with the FDA's decision to update the XTANDI label with these data from the first and largest comparative trial that demonstrated safety and efficacy of enzalutamide compared to bicalutamide. We believe these data will help physicians better understand the differences between enzalutamide and bicalutamide for their patients living with metastatic CRPC."

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On April 1, the company indicated that the Committee for Medicinal products for Human Use (CHMP) recommended approval of a type II variation to add TERRAIN study data in the XTANDI label as far as the European Union is concerned.

Based on a study, Pfizer said that about 181,000 fresh cases of prostate cancer would be diagnosed every year. The American Cancer Society estimates 26,000 men to die in the current year because of the disease.

At time of writing this, the stock shed 0.8 percent to $32.28.

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