FDA Approves Genentech’s Avastin (Bevacizumab) Plus Chemotherapy To Treat Women With Platinum-Resistant Recurrent Ovarian Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Avastin® in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. The approval was based on results from the Phase III AURELIA study that showed Avastin plus chemotherapy reduced the risk of disease worsening or death (progression-free survival or PFS) by 62 percent compared to women who received chemotherapy alone (median PFS: 6.8 vs. 3.4 months, Hazard Ratio (HR)=0.38; p<0.0001). Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications, but also included high blood pressure and pain, redness or swelling of the hands or feet from the Phase III study.

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