FDA approves Vegzelma, biosimilar to Avastin, for treatment of six cancer types
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The FDA approved bevacizumab-adcd for treatment of six cancer types, according to a press release from the biosimilar’s manufacturer.
Bevacizumab-adcd (Vegzelma, Celltrion USA), a biosimilar to bevacizumab (Avastin, Genentech), is a recombinant humanized monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and prohibits it from binding to VEGFR-1 and VEGFR-2 on the surface of endothelial cells.
FDA approved bevacizumab-adcd for metastatic colorectal cancer; recurrent or metastatic nonsquamous non-small cell lung cancer; metastatic renal cell carcinoma; recurrent glioblastoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.
Evidence that served as the basis for FDA approval included results of a pivotal phase 3 trial among patients with metastatic or recurrent nonsquamous NSCLC. The findings, presented at this year’s American Association for Cancer Research Annual Meeting, showed bevacizumab-adcd to be highly similar to reference bevacizumab with regard to safety, efficacy and pharmacokinetics as first-line treatment.
“Biosimilars have been used in many disease areas, including oncology, and have shown to be safe and effective while lowering the drug cost and increasing access to more patients around the world,” Claire F. Verschraegen, MD, director of the division of medical oncology at The Ohio State University Comprehensive Cancer Center, said in the press release. “With the availability of biosimilars such as Vegzelma in the U.S., oncologists will have additional treatment options for patients across multiple cancer types.”
The most common adverse reactions with bevacizumab-adcd include pistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis, the press release stated.
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