FDA approves updated label for Xtandi in prostate cancer

The US Food and Drug Administration approved a supplemental New Drug Application (sNDA) to update the US product labeling for Xtandi (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study.

The data demonstrate improvement in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.

Xtandi, which is already generating annual sales in excessive of $2.2 billion for Japan’s Astellas Pharma (TYO: 4503), which entered into an agreement with Medivation in 2009 to develop Xtandi globally and commercialize jointly in the USA. However, US pharma giant Pfizer (NYSE: PFE) acquired Medivation in a $14 billion deal earlier this year, outbidding others, including Sanofi, AstraZeneca, Celgene, Gilead Sciences and Merck & Co, and therefore now has joint rights to the drug.