CHMP positive for Tizveni (tislelizumab) to treat locally advanced or metastatic non small lung cancer. BeiGene.
On 22 February 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tizveni, intended for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) either in monotherapy or in combination with chemotherapy.
The applicant for this medicinal product is Beigene Ireland Limited.
Tizveni will be available as a 100 mg concentrate for solution for infusion. The active substance of Tizveni is tislelizumab, an antineoplastic agent (ATC code: L01FF09). Tislelizumab is a humanised IgG4 variant monoclonal antibody that potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2 ligands.
The benefit of Tizveni is an improvement in overall survival and progression free survival in patients with locally advanced or metastatic NSCLC, as shown in three open-label, randomised phase III studies comparing Tizveni (either in monotherapy or in combination) with chemotherapy. The most common side effects are anaemia, fatigue and increased AST.
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