The FDA on Wednesday approved Bayer HealthCare's Xofigo injection for advanced prostate cancer, three months ahead of schedule. Xofigo had a priority review status with a decision date of Aug. 14, 2013.
Xofigo with the active ingredient radium 223 dichloride (radium 223) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases.
The approval of Xofigo was based on a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Men treated with Xofigo lived a median of 14 months compared to a median of 11.2 months for men receiving placebo in the trial.
Bayer has worldwide exclusive marketing rights for Xofigo. In the U.S., Bayer HealthCare and Algeta US, LLC will co-promote the product.
Xofigo is the second prostate cancer drug to be approved by the FDA in less than a year.
Last August, the FDA approved Xtandi 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. Xtandi is co-marketed by Astellas Pharma U.S., Inc. and Medivation Inc.
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