EU validates filing of tislelizumab in non-small cell lung cancer
Novartis announced that the European Medicines Agency (EMA) validated Marketing Authorization Applications (MAAs) for the immune checkpoint inhibitor tislelizumab for adults with locally advanced or metastatic, squamous or non-squamous non-small cell lung cancer (NSCLC) as first-line treatment in combination with chemotherapy and locally advanced or metastatic NSCLC as monotherapy after prior chemotherapy.
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody being developed both as a monotherapy and in combination with other therapies.
The MAAs include data from the pivotal Phase III RATIONALE 303 trial, which showed tislelizumab significantly improved overall survival versus chemotherapy in people with NSCLC after treatment with chemotherapy, and from RATIONALE 304 and 307, which showed tislelizumab plus chemotherapy significantly improved progression-free survival versus chemotherapy in people with untreated squamous and non-squamous NSCLC.
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