FDA stalls Amgen's Xgeva sBLA for prevention of bone metastases

30 April 2012

USA-based Amgen (Nasdaq: AMGN) revealed on Friday that the US Food and Drug Administration has issued a Complete Response Letter relating to its supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to treat men with castration-resistant prostate cancer (CRPC) at high risk of developing bone metastases.

Recently-launched Xgeva, which is already approved to prevent fractures in patients with advanced prostate cancer that has migrated to the bone, generated first-quarter 2012 sales of $153 million, up 14% over the last quarter of 2011. Amgen, the world’s largest biotech company, is seeking additional approval for use to postpone or prevent the cancer's spread.

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