Novartis announces anti-PD-1 tislelizumab accepted by EMA for regulatory review in esophageal and lung cancers

PRESS RELEASE Corporate Announcements


Novartis AG

Basel, April 6, 2022 — Novartis today 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, - Locally advanced or metastatic NSCLC as monotherapy after prior chemotherapy, and - Unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) 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.

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