CHMP recommends Tevimbra to treat oesophageal squamous cell carcinoma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tevimbra (Baizen in China) intended for the treatment of oesophageal squamous cell carcinoma
The applicant for this medicinal product is Novartis Europharm Limited.
The benefit of Tevimbra is an improvement in overall survival in patients with advanced or metastatic oesophageal squamous cell carcinoma, as shown in an open-label, randomised phase 3IIIstudy comparing Tevimbra with ICC. The most common side effect is anaemia.
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