Merck KGaA dips after EU regulator calls for review of Erbitux

25 March 2010

German drug major Merck KGaA is reviewing cardiac risks of its oncology drug Erbitux (cetuximab) in several types of cancer after the European Medicines Agency (EMEA) asked for more information on its safety. The news caused the firm's stock to slip 1% in morning trading today.

This is further bad news for the drug, which is already approved for use against cancer of the bowel and of the head and neck, but was rejected for a second time for extended use in advanced non-small cell lung cancer by the EMEA's advisory committee last year when the Committee for Medicinal Products for Human Use (CHMP) said its benefits did not outweigh its risks (The Pharma Letter November 20, 2009).

The EMEA requested the review after rejecting Erbitux for use in lung cancer patients, according to a report published on-line on March 12. The drug regulator identified an 'increased incidence of cardiac events' in lung cancer patients aged 65 years or more, in particular high-risk patients with a history of heart problems.

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