EU validates filing of tislelizumab in oesophageal squamous cell carcinoma
Novartis announced that the European Medicines Agency (EMA) validated Marketing Authorization Applications (MAAs) for the immune checkpoint inhibitor tislelizumab for adults with unresectable, recurrent, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) 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 MAA includes data from the pivotal Phase III RATIONALE 302 trial, in which tislelizumab demonstrated a significant improvement in overall survival versus chemotherapy as treatment for people with OSCC who had received prior chemotherapy.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.