ON JUNE 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer. Like the reference product, the monoclonal antibody biosimilar bevacizumab-bvzr works by inhibiting angiogenesis by specifically recognizing and binding to vascular endothelial growth factor protein.
The FDA approval was based on a review of a comprehensive data package that demonstrated biosimilarity of bevacizumab-bvzr to the reference product. These data include results from the REFLECTIONS B7391003 clinical comparative study, which showed clinical equivalence and found no clinically meaningful differences between bevacizumab-bvzr and the reference product in patients with advanced nonsquamous NSCLC. As part of the REFLECTIONS clinical trial program, bevacizumab-bvzr has been studied in nearly 400 patients to date.
Bevacizumab-bvzr was also approved for use in the European Union in February 2019 for the treatment of metastatic carcinoma of the colon or rectum; metastatic breast cancer; unresectable advanced, metastatic, or recurrent NSCLC; advanced and/or metastatic renal cell carcinoma; and persistent, recurrent, or metastatic carcinoma of the cervix. ■