News
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
News
The approval was based on data from a phase 3 POSEIDON study.
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.
News
The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial.
News
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
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.
News
The Food and Drug Administration has granted accelerated approval to Tabrecta™ (capmatinib; Novartis).
Drugs in the Pipeline
The sBLA is supported by data from the IMpower010 study that compared atezolizumab with best supportive care in 1005 adults with Stage IB-IIIA NSCLC after resection and adjuvant chemotherapy.
Drugs in the Pipeline
Patritumab deruxtecan consists of a fully human anti-HER3 IgG1 monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via a stable tetrapeptide-based cleavable linker.
News
The approval was based on data from the phase 1 CHRYSALIS trial that evaluated Rybrevant in 81 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.