The application is supported by data from the registration-enabling cohort of the phase 2 KRYSTAL-1 study evaluating adagrasib in adults with NSCLC harboring the KRASG12C mutation following prior systemic therapy.
A PDUFA target date of November 24, 2022 has been set for the application.
Sugemalimab improved progression-free survival whether patients received sequential or concurrent chemoradiotherapy.
There was no improvement in overall survival with bevacizumab.
There was an improvement in progression-free survival despite crossover.
No difference in overall survival seen with nivolumab plus ipilimumab, nivolumab alone for advanced, chemotherapy-pretreated disease
The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial.
The Food and Drug Administration has placed sotorasib under priority review for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
Investigators studied genetic alterations related to ALK-TKI resistance in NSCLC and explored strategies to overcome resistance in preclinical models.
This study tested the efficacy of singular and combined treatment modalities on survival in patients with inoperable, locally advanced non-small cell lung cancer (≥70 years).
