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.
Respiratory and Thoracic Cancers
FDA Rejects Sintilimab Combo for First-Line Treatment of Nonsquamous NSCLC
Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.
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.
Exkivity Approved for EGFR Exon 20 Insertion+ NSCLC
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.
Lumakras Gets Accelerated Approval for KRAS G12C-Mutated NSCLC
The Food and Drug Administration (FDA) has granted accelerated approval to Lumakras (sotorasib) for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least 1 prior systemic therapy. Sotorasib, an inhibitor of the RAS GTPase family, works by…
Rybrevant Approved for NSCLC With EGFR Exon 20 Insertion Mutations
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.
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