FDA Accepts Biologics License Application for Proposed Biosimilar to Bevacizumab
Posted: Wednesday, March 11, 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 treatment of patients with nonsquamous non–small cell lung cancer (NSCLC). Bevacizumab is also being reviewed for treatment of patients with colorectal cancer; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent, or metastatic cervical cancer.
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 NSCLC (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.