Roche granted FDA Priority Review for obinutuzumab in the treatment of chronic lymphocytic leukemia

3 July 2013

Swiss drug major Roche (ROG: SIX) has announced today (July 3) that the US Food and Drug Administration has granted Priority Review for obinutuzumab (GA101) in the treatment of chronic lymphocytic leukemia (CLL) based on based on final stage 1 data from the CLL11 trial.

This is the second such status granted to a Roche drug this week. The company’s HER2-positive breast cancer drug Perjeta (pertuzumab) gained priority rating on Monday (The Pharma Letter July 2, 2013).

The FDA has accepted the company’s Biologics License Application for obinutuzumab used to treat one of the most common forms of blood cancer and confirmed the PDUFA action date is December 20, 2013. This acceptance follows the GA101 FDA Breakthrough Therapy Designation that was received in May 2013.

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