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.

Vegzelma has also been approved in the EU, the UK and Japan.