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FDA grants priority review to Bayer's regorafenib
June 28, 2012 / 8:05 AM / 5 years ago

FDA grants priority review to Bayer's regorafenib

(Reuters) - Health regulators granted a priority review for Bayer’s colorectal cancer drug regorafenib, potentially speeding up the experimental treatment’s route to market.

Werner Wenning, nominated Chairman of Supervisory Board of Bayer AG is silhouetted as he poses before the annual general meeting in Cologne April 27, 2012. REUTERS/Ina Fassbender

The Food and Drug Administration grants priority reviews to medicines that are considered potentially significant therapeutic advancements over existing therapies.

A priority review takes six months rather than the usual 10 to 12-months.

Regorafenib aims to treat patients whose metastatic colorectal cancer has worsened after standard therapy.

Onyx Pharmaceuticals is the U.S. marketing partner for the drug.

The companies also cooperate on a compound similar to regorafenib called Nexavar.

Regorafenib had become a bone of contention between Bayer and Onyx in 2009, when Onyx said the compound should be treated as an offshoot from their joint Nexavar project while Bayer laid sole claim to the drug but the dispute has been settled.

Both Nexavar and regorafenib are so-called multikinase inhibitors that quell cancer cell growth and prevent new blood vessels that could feed tumors.

Bayer, the inventor of Aspirin which also makes plastics and pesticides, is also testing regorafenib against a number of tumor types including kidney cancer.

Reporting by Balaji Sridharan in Bangalore; Editing by Mike Nesbit

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