The manufacturer of bevacizumab (Avastin), snagged FDA approval for yet another type of cancer.
Genentech’s Avastin, in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, is approved for the treatment of women with advanced (stage 3 or 4) ovarian cancer following initial surgical resection.
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Avastin is now approved in the United States for 10 distinct uses across 6 different types of cancer. This indication represents Avastin’s fourth gynecologic oncology indication in 4 years, including advanced cervical cancer and 2 different forms of ovarian cancer.
“This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery,” said Melissa Aucoin, CEO of the National Ovarian Cancer Coalition (NOCC), in a Genentech statement. “Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers.”
The approval for Avastin for advanced ovarian cancer is based a Phase 3 trial, which found that women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12 months in women who received chemotherapy alone. “This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total),” Genentech said.
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