Fast FDA approval for Bayer's new drug for advanced prostate cancer, Xofigo

The US Food and Drug Administration yesterday (May 15) approved Xofigo (radium Ra 223 dichloride, initially called Alpharadin), from German drug major Bayer (BAYN: DE), to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer.

Xofigo is to be marketed by Bayer’s US subsidiary and Norway’s Algeta (OSE: ALGETA), which licensed the drug to the German firm under a deal worth a potential $800 million signed in 2009. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA, that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III ALSYMPCA trial, commented Algeta, which said that the commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks..

The drug is not currently approved in other markets, but Bayer submitted a Marketing Authorization Application to the European Medicines Agency for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases.