Medivation, Astellas seek to expand Xtandi's U.S. label

Medivation Inc. (NASDAQ:MDVN) and partner Astellas Pharma Inc. (Tokyo:4503) said Astellas submitted an sNDA to FDA for Xtandi enzalutamide to treat chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). The companies plan to submit an MAA to EMA to add the indication to the European label later this year. Xtandi is already approved in more than 35 countries, including the U.S. and EU, for CRPC patients previously treated with docetaxel.

Last month, Medivation introduced 2014 U.S. Xtandi sales guidance of $500-$535 million. The oral androgen receptor antagonist had U.S. sales of $392.4 million in 2013 -- the first full year the drug was on the U.S. market (see BioCentury Extra, Feb. 28). ...