Genentech (South SF) Submits Supplemental Applications to FDA for Avastin Combined with Commonly Used Chemotherapies for Women with Advanced Breast Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for AvastinĀ® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy. The other is based on the Phase III study RIBBON 1 that investigated Avastin in combination with a taxane, anthracycline-based or capecitabine chemotherapy. Both studies met their primary endpoints of improving the time women lived without the disease worsening (progression-free survival or PFS).

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