On September 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic nonsquamous non–small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Bevacizumab-adcd is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1) and kinase insert domain receptor (VEGFR-2) on the surface of endothelial cells.
“Biosimilars have been used in many disease areas including oncology and have [been] shown to be safe and effective while lowering the drug cost and increasing the access to more patients around the world,” said Claire F. Verschraegen, MD, Director of the Division of Medical Oncology at The Ohio State University Comprehensive Cancer Center. “With the availability of biosimilars such as bevacizumab-adcd in the United States, oncologists will have additional treatment options for patients across multiple cancer types.”
The FDA approval of bevacizumab-adcd was based on the totality of evidence, including the pivotal phase III trial in patients with metastatic or recurrent nonsquamous NSCLC. Results showed that as a first-line treatment, bevacizumab-adcd is highly similar to the reference product in terms of efficacy, safety, and pharmacokinetics. These findings were presented at the 2022 American Association for Cancer Research Annual Meeting (Abstract CT551).
