Biotechnology company Medivation Inc. (MDVN) Friday said its late-stage prostate cancer drug, which it developed with Astellas Pharma Inc, has received US Food and Drug Administration's approval.
The drug, to be sold under the name Xtandi, was approved for the treatment of men with late-stage castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
Xtandi, or enzalutamide, is an oral once-daily androgen receptor inhibitor.
Xtandi, which received the approval three months ahead of scheduled date, extends survival of patients to 18.4 months, compared with 13.6 months for the patients who received placebo, FDA said in a statement.
"The need for additional treatment options for advanced prostate cancer continues to be important for patients," said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."
Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow.
Medivation Chief Executive David Hung said, "Today's approval marks a significant accomplishment for Medivation. We are proud to be in a position to offer a new treatment, XTANDI, for this patient population for which there is a significant unmet medical need."
Medivation expects to launch the drug in US markets by mid-September of 2012.
The drug has also been accepted for review by the European Medicines Agency, the drug regulatory body in Europe.
Shares of MDVN closed Friday's trading at $104.86, up 7.64%, on a volume of 1.1 million shares. The stock further gained 0.28% in after hours.
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