Tevimbra (tislelizumab), MAH: BeiGene Ireland Ltd
date: 01/04/2025
See also: Summary of opinion
On 27 March 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Tevimbra.
The CHMP adopted a new indication as follows: (1)
Small Cell Lung Cancer (SCLC)
Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
(1) New text in bold