FDA accepts Roche’s sBLA for Avastin

Biosimilar News  •  U.S. FDA News

This week Roche reported that FDA has accepted their supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab) “in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer.”

The sBLA is for the use of Avastin® with carboplatin and paclitaxel, followed by administration of Avastin® as a single agent, for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. Their application is based on a Phase III multi-center, randomized, double-blind, placebo-controlled 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.” Results from that trial demonstrated that “[w]omen 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 (PFS) 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).” Roche indicated that FDA is expected to make a decision on approval by June 25, 2018.

Roche further stated that Genentech is also evaluating “Avastin in combination with Tecentriq® (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer” in a Phase III study (NCT03038100).

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