FDA Accepts Biologics License Application for Proposed Biosimilar to Bevacizumab
Posted: Thursday, March 12, 2020
On March 9, the U.S. Food and Drug Administration (FDA) approved a biologics license application for MYL-1402O, a proposed biosimilar to bevacizumab, as a first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy. Bevacizumab is also under review as a potential treatment for patients with non–small cell lung, cervical, and kidney cancers.
The application approval is based on study results from a global phase III clinical trial evaluating the efficacy, safety, and immunogenicity of the proposed biosimilar to bevacizumab versus the Avastin brand of bevacizumab in patients with stage 4 nonsquamous non–small cell lung cancer (n = 671). Patients were randomly administered either the proposed biosimilar to bevacizumab or Avastin along with carboplatin and paclitaxel for 18 weeks and then given monotherapy until week 42. Patients benefiting from the treatment continued with bevacizumab monotherapy. The primary endpoint of best overall response rate was met, at a 90% confidence interval at week 18. The safety profile, which included immunogenicity, was similar to that of Avastin.