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12:00 AM
Oct 08, 2007
 |  BioCentury  |  Product Development

K-Rationalizing Vectibix use

Amgen Inc. recently convinced EMEA to reverse a negative opinion on Vectibix panitumumab based in part on biomarker data from a Phase III trial that showed how to focus use of the drug in patients for whom it works. For the same reason, the data ultimately may help U.S. sales of the drug, which have been sluggish. The key in both regions will be getting a diagnostic on the market.

AMGN confirmed that efficacy of the anti-EGFR antibody was confined to the subset of metastatic colorectal cancer patients with wild-type K-Ras (KRAS) gene expression. Its first order of business now will be to work with partners to make sure a diagnostic for K-Ras status becomes commercially available - one of the conditions for the antibody's approval in Europe.

In September 2006, AMGN (Thousand Oaks, Calif.) received accelerated approval from FDA based on an open-label Phase III trial that showed metastatic colorectal cancer patients receiving Vectibix plus best supportive care had significantly longer mean progression-free survival than patients receiving best supportive care alone (96 days vs. 60 days, p<0.0001).

Based on the same data, EMEA's CHMP recommended against approval in May,...

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