The European Commission has granted approval for tislelizumab (Tizveni) as a treatment for patients with non-small cell lung cancer (NSCLC), applicable in both frontline and second-line settings. This decision was announced by BeiGene, Ltd., the developers of the drug. Tislelizumab is approved for use in combination with carboplatin and either paclitaxel or nab-paclitaxel as a frontline therapy for adults with squamous NSCLC who are not suitable for surgery and platinum-containing chemoradiation, or those with metastatic disease. Additionally, it has been approved in combination with pemetrexed and platinum-based chemotherapy for adults with metastatic disease or nonsquamous histology, PD-L1 expression in at least 50% of tumor cells, and no EGFR or ALK mutations.
Tislelizumab is also approved as a monotherapy for adult patients with locally advanced or metastatic NSCLC following prior platinum-based treatment. Patients with EGFR mutations or ALK-positive disease may receive tislelizumab after treatment with prior targeted therapies.
The approval is supported by data from three phase 3 trials: RATIONALE 307, RATIONALE 304, and RATIONALE 303, which collectively included 1499 patients with NSCLC. These studies demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with tislelizumab compared to those receiving standard chemotherapy. Common adverse effects included decreases in neutrophil levels, neutropenia, and leukopenia.
Luis Paz-Ares, MD, PhD, highlighted the importance of this approval, noting that NSCLC remains one of the most common and deadly cancers in Europe, with many patients diagnosed at advanced stages. The approval of tislelizumab offers a new treatment option for these patients, potentially improving outcomes and survival rates.
The European Medicine Agency’s Committee for Medicinal Products for Human Use issued a positive opinion in support of tislelizumab in February 2024, paving the way for its approval and availability in the European Union later in the year.
