Drugs in the Pipeline
A PDUFA target date of November 24, 2022 has been set for the application.
Drugs in the Pipeline
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.
Drugs in the Pipeline
The sBLA is supported by data from the phase 2 DESTINY-Lung01 trial, along with a phase 1 trial published in Cancer Discovery.
Drugs in the Pipeline
Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.
Drugs in the Pipeline
The phase 3 study compared tiragolumab plus atezolizumab with placebo plus atezolizumab in adults with PD-L1 high locally advanced, unresectable or metastatic NSCLC.
Drugs in the Pipeline
Tiragolumab is a monoclonal antibody that works by binding to TIGIT, a protein receptor on immune cells, and suppresses the immune response to cancer.
Drugs in the Pipeline
The sBLA was supported by data from the phase 3 TOPAZ-1 trial.