Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC
The approval was based on data from the KEYNOTE-091 trial.
The approval was based on data from the KEYNOTE-091 trial.
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
According to the CRL, the application could not be approved in its present form as additional data, including a randomized controlled trial, would be required.
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
Vegzelma is a vascular endothelial growth factor inhibitor.
The phase 3 study compared tiragolumab plus atezolizumab with placebo plus atezolizumab in adults with PD-L1 high locally advanced, unresectable or metastatic NSCLC.
Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.
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.
Exkivity (mobocertinib) is approved to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.