U.S. License Holder:
Celltrion
Date of License:
September-27-2022
Last Update:
Nov-15-2024
FDA-Approved Indications
VEGZELMA (bevacizumab-adcd) is a vascular endothelial growth factor inhibitor indicated for the treatment of:
Metastatic colorectal cancer, in combination with intravenous 5-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 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; in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens; in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Vegzelma as a single agent, for platinum-sensitive recurrent diesase.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Vegzelma® (Celltrion) (January-2023)
Biosimilars Approved In The E.U.
Vegzelma® (Celltrion) (August-2022, UK: September-2022)
Biosimilars Approved In Australia
Vegzelma® (Celltrion) (September-2023)
Biosimilars Approved In Japan
Vegzelma® (Celltrion) (September-2022)
