BLA 761268, held by Celltrion. Bevacizumab-Adcd.
As of Nov 13, 2026, BLA 761268 (Vegzelma), held by Celltrion, was first approved by FDA on Sep 27, 2022, with 0 approved supplements and 0 published complete response letters.
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. Limitations of Use: VEGZELMA is not indicated for adjuvant treatment of colon cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vegzelma100MG/4ML(25MG/ML) · injectable;injection | Bevacizumab-Adcd | Rx |
| Vegzelma400MG/16ML(25MG/ML) · injectable;injection | Bevacizumab-Adcd | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
