FDA Accepts Roche's Avastin Applications

By Marc Bisbal Arias Features Dow Jones Newswires

Roche Holding AB (ROG.EB) said Thursday that the U.S. Food and Drug Administration accepted its supplemental biologics licence application for Avastin in combination with chemotherapy, as well as Avastin alone.

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The FDA is expected to make a decision on approval by June 25, 2018.

Avastin is a drug used for cancer treatment.

The application is part of Roche's broader development program for Avastin in the treatment ovarian cancer, the company said, adding that the drug is currently approved for treating two different forms of advanced disease that recurred after platinum-based chemotherapy.

"We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible," Chief Medical Officer Sandra Horning said.

Write to Marc Bisbal Arias at marc.bisbalarias@dowjones.com

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(END) Dow Jones Newswires

October 26, 2017 01:58 ET (05:58 GMT)