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The Food and Drug Administration (FDA) has approved Vegzelma® (bevacizumab-adcd), a biosimilar to Avastin® (bevacizumab). The approval of Vegzelma was based on the totality of evidence demonstrating that Vegzelma was highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.
Vegzelma is a vascular endothelial growth factor 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 product-containing regimen.
- Unresectable, locally advanced, recurrent or metastatic non-squamous 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.
- Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, in combination with carboplatin and paclitaxel, followed by Vegzelma as a single agent.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease in patients who received no more than 2 prior chemotherapy regimens.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Vegzelma as a single agent for platinum-sensitive recurrent disease.
Vegzelma is not indicated for adjuvant treatment of colon cancer. Lack of efficacy of bevacizumab as an adjunct to standard chemotherapy for the adjuvant treatment of colon cancer was determined in 2 randomized, open-label, multicenter clinical studies.
Vegzelma is supplied as a single-dose vial containing 100mg/4mL and 400mg/16mL of bevacizumab-adcd.
References
- Celltrion USA receives US FDA approval for its oncology biosimilar Vegzelma® (bevacizumab-adcd) for the treatment of six types of cancer. News release. Celltrion USA. Accessed September 28, 2022. https://www.businesswire.com/news/home/20220927006146/en/Celltrion-USA-Receives-U.S.-FDA-Approval-for-its-Oncology-Biosimilar-Vegzelma%C2%AE-bevacizumab-adcd-for-the-Treatment-of-Six-Types-of-Cancer
- Vegzelma. Package insert. Celltrion USA; 2022. Accessed September 28, 2022. https://www.celltrionhealthcare.com/en-us/draft-labeling-text.pdf
