Bevacizumab Biosimilar Avzivi Receives FDA Approval

The US Food and Drug Administration (FDA) has approved Avzivi (bevacizumab-tnjn), a biosimilar to Avastin (bevacizumab).

Avzivi is a VEGF inhibitor indicated for the treatment of:

• Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
• Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen.
• Unresectable, locally advanced, recurrent, or metastatic nonsquamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
• Recurrent glioblastoma in adults.
• Metastatic renal cell carcinoma in combination with interferon alfa.
• Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
• Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens.

The approval of Avzivi was based on a comprehensive data package that included a pharmacokinetic study (ClinicalTrials.gov Identifier: NCT05865574) in healthy individuals as well as a phase 3 comparative study (ClinicalTrials.gov Identifier: NCT03329911) in patients with advanced nonsquamous non-small cell lung cancer.

“The global phase 3 clinical trial has confirmed that Avzivi is highly similar to Avastin in terms of efficacy, safety, and immunogenicity,” said Li Zhang, lead investigator of the global phase 3 study of Avzivi. “The approval of Avzivi by the FDA will provide lung and colorectal cancer patients a new cost-effective treatment option.”

Reference

FDA approves Bio-Thera Solutions’ Avzivi® (bevacizumab-tnjn), a biosimilar referencing Avastin®. News release. Bio-Thera. December 7, 2023. https://www.prnewswire.com/news-releases/fda-approves-bio-thera-solutions-avzivi-bevacizumab-tnjn-a-biosimilar-referencing-avastin-302009433.html.

This article originally appeared on Cancer Therapy Advisor