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Roche's Avastin combo wins US FDA nod for expanded use in ovarian cancer


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Roche's Avastin combo wins US FDA nod for expanded use in ovarian cancer

The U.S. Food and Drug Administration approved a combination of Roche Holding AG's blockbuster medicine Avastin and chemotherapy for treating women with advanced ovarian cancer who had undergone surgery.

Avastin, which recorded sales of about CHF6.7 billion in 2017, is now approved in the U.S. for 10 uses across six types of cancer.

The Basel, Switzerland-based pharmaceuticals giant said the U.S. regulator approved Avastin to be used in combination with chemotherapy drugs carboplatin and paclitaxel, followed by Avastin alone, for treating women with stage 3 or stage 4 epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgery.

Roche unit Genentech Inc., which submitted the biologics license application to the U.S. regulator in October 2017, said the approval was based on data from its phase 3 trial, named GOG-0218, which showed that patients on the Avastin and chemotherapy combination, followed by continued use of Avastin alone, lived for a median of 18.2 months without the disease progressing, compared to 12 months for those who just received chemotherapy.

Avastin is also being evaluated in combination with other medicines to treat certain other cancer types.

At the American Society of Clinical Oncology meeting Roche said the combination regimen of its drugs Tecentriq and Avastin along with chemotherapy stopped cancer from growing in certain lung cancer patients.