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Horizon scanning: Bayer to seek US Food and Drug Administration approval for regofarenib for the treatment of colorectal cancer

Source: PharmaTimes

Date published: 18/01/2012 17:01

Summary
by: Hina Radia

PharmaTimes has reported that Bayer Pharmaceuticals has filed for the approval of regorafenib for the treatment of colorectal cancer following an announcement of outcome data from the CORRECT trial which showed that the drug improved overall survival by 29%.

 

In October, the Phase III CORRECT trial, which involved 760 patients with metastatic colorectal cancer was stopped early following an interim analysis which showed favourable overall survival in patients randomised to regorafenib, so that all participants would be offered treatment with regorafenib, an oral multi-kinase inhibitor. The PharmaTimes abstract reports that people on the drug lived a median 6.4 months longer, compared with 5 months for those on placebo (an absolute difference of 1.4 months).

 

Detailed statistical data were not available from this abstract.

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