Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC
The approval was based on data from the KEYNOTE-091 trial.
Diagnosis & Disease Information
Krazati Approved for KRASG12C-Mutated Locally Advanced or Metastatic NSCLC
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
FDA Passes on Poziotinib for HER2 Exon 20 Insertion Mutation-Positive NSCLC
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.
Libtayo Plus Chemotherapy Approved as First-Line Treatment for Advanced NSCLC
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
Bevacizumab Biosimilar Vegzelma Gets FDA Approval
Vegzelma is a vascular endothelial growth factor inhibitor.
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.
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.
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