FDA Agrees to Review sBLA for Reference Bevacizumab

The FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for its innovator bevacizumab (Avastin) in combination with carboplatin and paclitaxel chemotherapy, followed by Avastin alone, for the front-line treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Avastin, an angiogenesis inhibitor, is currently approved for treatment of 2 different forms of advanced cancer that recurred after platinum-based chemotherapy (non-squamous non—small cell lung cancer, carcinoma of the colon or rectum, and renal cell carcinoma). The FDA is expected to decide on whether to approve the new indication for Avastin by June 25, 2018.

This sBLA for Avastin, in the combination and order of treatment as specified, is based on data from the pivotal phase 3 GOG-0218 trial, which was conducted by the Gynecologic Oncology Group and published in The New England Journal of Medicine. GOG-0218 was a multicenter, randomized, double-blind, placebo-controlled phase 3 study in 1873 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. Study participants were randomized to 1 of 3 treatment arms:

• Chemotherapy alone (carboplatin and paclitaxel) (n = 625)

• Avastin (15 mg/kg) plus chemotherapy followed by placebo alone (n = 625)
• Avastin plus chemotherapy followed by Avastin alone (n = 623)

Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a duration of 22 cycles, lived the longest without disease progression, with a median progression-free survival of 18.2 months compared with 12.0 months in women who received chemotherapy alone (hazard ratio, 0.64; 95% confidence interval, 0.54-0.77; P < .001).

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 company said.

The sBLA seeking the new indication follows closely on the heels of the FDA’s approval of Amgen’s bevacizumab biosimilar, ABP 215 (Mvasi), the first biosimilar of Avastin approved for use in the United States. Amgen, seeking to launch its product, is currently engaged in a lawsuit against Genentech in a California district court. Amgen seeks a judgment that its biosimilar has not infringed on 27 patents covering the reference bevacizumab. When Amgen eventually brings Mvasi to the US marketplace, the biosimilar will compete for a share of substantial bevacizumab sales; Avastin was responsible for $6.75 billion in global sales for Genentech in 2016.