Drugs / CT-P16
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT03247673 | Aug → Dec 2017 | — | Celltrion | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03676192 | Feb 2019 → Apr 2021 | lung adenocarcinoma | Celltrion | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-09-28 | Celltrion | Regulatory Celltrion USA receives U.S. FDA approval for its oncology biosimilar Vegzelma® (bevacizumab-adcd) for the treatment of six types of cancer celltrion.com ↗ |
| 2022-08-19 | Celltrion | Regulatory European Commission approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer celltrion.com ↗
European Commission approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the treatment of multiple types of cancer |
| 2022-06-27 | Celltrion | Regulatory Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma™ (CT-P16) celltrion.com ↗
Celltrion Healthcare announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation of a bevacizumab biosimilar candidate, referencing EU-approved Avastin®, Vegzelma™ (CT-P16). |
All press releases naming this drug 6 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT-P16 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03247673 ↗ |
| Known as | bevacizumab | “CT-P16 is a candidate bevacizumab biosimilar.” PMID 36169807 ↗ Sep 2022 |
| Modality | Monoclonal antibody | “CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers.” PMID 30850957 ↗ Apr 2019 |
| Route | Intravenous | “CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects” NCT03247673 ↗ |