FDA approves new treatment for prostate cancer

Hannah Blake

pharmaphorum

The US FDA has approved a new treatment, co-developed by pharmaceutical companies Astellas and Medivation, for patients with an advanced form of prostate cancer. Xtandi (enxalutamide) has been approved three months ahead of the product’s prescription drug user fee goal date of November 22nd 2012.

Xtandi has been approved to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

The FDA reviewed Xtandi under its priority review program, as the treatment is already approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment.

“The need for additional treatment options for advanced prostate cancer continues to be important for patients. Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

The FDA’s priority review program provides an expedited six-month review for drugs that may offer major advances in treatment, or that provide a treatment when no adequate therapy exists.

A clinical study of 1,199 men with metastic castration-resistant prostate cancer, who had received prior treatment with docetaxel, evaluated the safety and effectiveness of Xtandi. The study found that the median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.

 EU-Clinical-Trial-Directive-Regulatory-Requirements-20Sep12

Related news:

Xtandi: Prostate Cancer Drug Approved By FDA (Huffington Post)

Reference links:

FDA

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