Vegzelma FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 29, 2022.
FDA Approved: Yes (First approved September 27, 2022)
Brand name: Vegzelma
Generic name: bevacizumab-adcd
Dosage form: Injection
Company: Celltrion USA
Treatment for: Colorectal Cancer, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Vegzelma (bevacizumab-adcd) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Vegzelma is indicated for the treatment of:
- Metastatic colorectal cancer, in combination with intravenous fluorouracilbased chemotherapy for first- or second-line treatment; or in combination with fluoropyrimidineirinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
Limitations of Use: Vegzelma is not indicated for adjuvant treatment of colon cancer. - 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.
- Epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by Vegzelma as a single agent, for stage III or IV disease following initial surgical resection; or in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; or in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Vegzelma as a single agent, for platinum-sensitive recurrent disease.
- Metastatic colorectal cancer, in combination with intravenous fluorouracilbased chemotherapy for first- or second-line treatment; or in combination with fluoropyrimidineirinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
- Vegzelma is administered via intravenous infusion over 90 minutes for the first infusion, over 60 minutes for the second infusion if the first infusion is tolerated, and over 30 minutes for subsequent infusions if the second infusion over 60 minutes is tolerated.
- Warnings and precautions associated with Vegzelma include gastrointestinal perforations and fistula; surgery and wound healing complications; hemorrhage; arterial and venous thromboembolic events; hypertension; posterior reversible encephalopathy syndrome; renal injury and proteinuria; infusion-related reactions; embryo-fetal toxicity; ovarian failure; and congestive heart failure.
- Common adverse reactions include epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis.
- Vegzelma is the fourth approved biosimilar for Avastin following Mvasi (bevacizumab-awwb) in 2017, Zirabev (bevacizumab-bvzr) in 2019, and Alymsys (bevacizumab-maly) in 2022.
Development timeline for Vegzelma
| Date | Article |
|---|---|
| Sep 27, 2022 | Approval FDA Approves Vegzelma (bevacizumab-adcd), a Biosimilar to Avastin |
Further information
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