Amgen to appeal CHMP opinion on Vectibix for colorectal cancer in Europe

1 April 2011

USA headquartered Amgen (Nasdaq: AMGN), the world’s largest biotech firm, says that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued last month by the Committee For Medicinal Products for Human Use (CHMP for the use of Vectibix (panitumumab), in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC; The Pharma Letter March 21).

Amgen is looking to drive Vectibix sales by expanding the label into second - and first-line treatment of metastatic colorectal cancer, which will expand the patient base significantly. Vectibix' primary competitor is Eli Lilly/Bristol-MyersSquibb’s Erbitux (cetuximab).

Amgen believes that Vectibix, which generated sales of $288 million for 2010, a 24% year-on-year ruse, in combination with chemotherapy provides an important treatment option for patients with wild-type KRAS mCRC, and says it remains committed to patients with this aggressive disease, for whom there are limited treatment options.

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