Avastin Biosimilar Gets FDA Approval for Six Types of Cancer
Celltrion’s Vegzelma (bevacizumab-adcd) has received FDA’s approval for treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous nonsmall-cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent or metastatic cervical cancer; and epithelial ovarian, fallopian tube or primary peritoneal cancer.
Vegzelma is a biosimilar of Genentech’s Avastin (bevacizumab), a vascular endothelial growth factor inhibitor that is also FDA-approved in combination with atezolizumab for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The FDA approval was supported by results from a phase 3 study evaluating the drug in metastatic or recurrent nsNSCLC. Vegzelma as first-line treatment was shown to be similar to the reference product in terms of efficacy, safety and pharmacokinetics.
“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 the access to more patients around the world,” Claire Verschraegen, director of the Division of Medical Oncology at the Ohio State University Comprehensive Cancer Center, said in a press release. “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.”
Bevacizumab-adcd is the third oncology biosimilar produced by Celltrion gain FDA approval in the United States, with rituximab-abbs (Truxima) and trastuzumab-pkrb (Herzuma) both approved in 2018. Bevacizumab-adcd has also been approved in the European Union, the United Kingdom, and Japan in 2022, with regulatory reviews ongoing in other countries.
September 30, 2022
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