Astellas and Medivation file sNDA for new Xtandi indication

18 March 2014

Japanese drug major Astellas Pharma (TSE: 4503) and US partner Medivation (Nasdaq: MDVN) have filed a supplemental New Drug Application with the US Food and Drug Administration seeking approval of Xtandi (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.

Astellas’ shares closed up 2.4% at 6,109 yen on the Tokyo Stock Exchange, while Medivation gained 1.8% to $69.75 in morning trading in New York,

The sNDA application is based on the results from the Phase III PREVAIL trial evaluating Xtandi compared to placebo in more than 1,700 chemotherapy-naive mCRPC patients. The marketing authorization application is expected to be submitted to the European Medicines Agency later this year. Xtandi is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK