publication date: Oct. 27, 2017

Drugs and Targets

FDA accepts Genentech’s application for Avastin for advanced ovarian cancer

Genentech announced FDA has accepted the company’s supplemental Biologics License Application for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of advanced ovarian cancer.

This sBLA for Avastin for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer is based on data from the pivotal phase III GOG-0218 trial.

FDA is expected to make a decision on approval by June 25, 2018.

Avastin is approved for treating two different forms of advanced disease that recurred after platinum-based chemotherapy. In addition, Genentech is evaluating Avastin in combination with Tecentriq (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer in the phase III IMagyn050 trial (NCT03038100).

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible.

Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone.

Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.64; 95% CI 0.54 – 0.77, p<0.0001). Secondary endpoints of the study included overall survival and objective response rate. Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications.

The study was conducted by the Gynecologic Oncology Group and their initial results … Continue reading FDA accepts Genentech’s application for Avastin for advanced ovarian cancer

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