Tabrecta Granted Full Approval for Metastatic NSCLC Based on Confirmatory Data
The full approval was based on data from an additional 63 adults with metastatic NSCLC with confirmed MET exon 14 skipping as well as 22 months of follow-up time.
Respiratory and Thoracic Cancers
Trial Evaluating Tiragolumab Combo in PD-L1 High NSCLC Misses PFS Endpoint
The phase 3 study compared tiragolumab plus atezolizumab with placebo plus atezolizumab in adults with PD-L1 high locally advanced, unresectable or metastatic NSCLC.
Bevacizumab Biosimilar Alymsys Gets FDA Approval
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
Trial Evaluating Tiragolumab Combo for Extensive-Stage SCLC Misses Endpoint
Tiragolumab is a monoclonal antibody that works by binding to TIGIT, a protein receptor on immune cells, and suppresses the immune response to cancer.
FDA Rejects Sintilimab Combo for First-Line Treatment of Nonsquamous NSCLC
Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.
Opdivo Plus Chemotherapy Approved for Neoadjuvant Treatment of Resectable NSCLC
The approval was based on data from the CHECKMATE-816 trial.
Adagrasib Under Review for Previously Treated KRAS G12C-Mutated NSCLC
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.
Poziotinib Under Review for Previously Treated HER2 Exon 20 Insertion Mutation Positive NSCLC
A PDUFA target date of November 24, 2022 has been set for the application.
Patritumab Deruxtecan Gets Breakthrough Tx Status for Metastatic EGFR-Mutated NSCLC
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.
Tecentriq Approved as Adjuvant Treatment for Early NSCLC
The approval was based on data from the phase 3 IMpower010 study.
