With strong Phase III results, Bayer wins priority review status for new Stivarga indication

4 January 2017

Bayer (BAYN: DE) has announced that its Supplemental New Drug Application (sNDA) for Stivarga (regorafenib) will be reviewed under the US Food and Drug Administration’s priority review scheme.

The decision means that the FDA should provide a decision on the German pharma major’s application within six months, boosting hopes that the company can reverse declining sales of the product.

Bayer has submitted an sNDA to market the anti-cancer therapy as a second-line treatment for a type of liver cancer called unresectable hepatocellular carcinoma (HCC).

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