Novartis ditches the monotherapy filing for its anti-PD-1
July 20, 2022 - Novartis ceases the monotherapy filing in newly diagnosed NSCLC after hearing feedback from the FDA on trial diversity for PD-1/L1 contenders.
Currently, most patients newly diagnosed with metastatic NSCLC get the combination of a PD-1/L1 inhibitor alongside chemotherapy rather than a single-agent immunotherapy.
Merck's Keytruda boasts a monotherapy approval in patients whose tumors express the PD-L1 biomarker, and Roche's Tecentriq also has a monotherapy label but in a PD-L1-high population.
https://www.fiercepharma.com/pharma/novartis-shelves-tislelizumab-fda-submission-monotherapy-non-small-cell-lung-cancer