Roche Secures FDA Approval for Avastin Plus Chemotherapy to treat Advanced Cervical Cancer

WASHINGTON - Aug. 15, 2014 - PRLog -- The U.S. Food and Drug Administration (FDA) has granted the approval of Roche’s Avastin® (bevacizumab) combined with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of advanced cervical cancer in women.

“With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread.”

FDA approval was based on the GOG-0240 study which is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG). The study  evaluated  the efficacy and safety of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in  452 women with persistent, recurrent or metastatic cervical cancer.

According to the clinical data from Roche:

·      The study met its primary endpoint of improving overall survival (OS) with a statistically significant 26 percent reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone (median OS: 16.8 months vs. 12.9 months; Hazard Ratio (HR)=0.74, p=0.0132).¹

·      The study showed women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone (45 percent [95% CI: 0.39%-0.52%] vs. 34 percent [95% CI 0.28%-0.40%]).¹

According to the National Cancer Institute an estimated 12,360 women will be diagnosed with cervical cancer in 2014, and approximately 4020 women will die from this debilitating condition.

Avastin is approved in the United States to treat five distinct tumors and was the first anti-angiogenic therapy available to treat patients with advanced cancer. Avastin is marketed by Genentech, a member of the Roche Group.

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