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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Colon Cancer |
| Drug: | Vegzelma (bevacizumab-adcd) (VEGF-A inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer
Published date:
08/18/2022
Excerpt:
Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.
Source:
Excerpt:
CONTRADICTING EVIDENCE: VEGZELMA is a vascular endothelial growth factor inhibitor indicated for
the treatment of... is not indicated for adjuvant treatment of colon cancer.
Source:
Title:
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma™ (CT-P16)
Published date:
06/24/2022
Excerpt:
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). The positive CHMP opinion was supported with a comprehensive data package and totality of evidence demonstrating biosimilarity to the reference product for indications including metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer....The therapeutic equivalence of CT-P16 and reference bevacizumab was demonstrated by way of objective response rate (ORR) during the induction study period.
