EU approves Vegzelma for breast cancer, non-small cell lung cancer, renal cell cancer, carcinoma of the colon or rectum, ovarian cancer and cervical cancer
Celltrion Healthcare announced 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
The EC approval of Vegzelma follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.
This approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics. Vegzelma (CT-P16) is Celltrion’s third oncology biosimilar approved for use in the EU, following the approval of Truxima (biosimilar rituximab) and Herzuma (biosimilar trastuzumab). Vegzelma was also filed for regulatory approval with the FDA in September 2021. Approval is expected during the third quarter of 2022.
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