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.
Imjudo Plus Imfinzi and Chemotherapy Approved for Metastatic NSCLC
The approval was based on data from a phase 3 POSEIDON study.
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.
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.
Sugemalimab Deemed Effective as Consolidation for Stage III Non-Small Cell Lung Cancer
Sugemalimab improved progression-free survival whether patients received sequential or concurrent chemoradiotherapy.
Adding Bevacizumab to Erlotinib Prolongs PFS in Non-Squamous Non-Small Cell Lung Cancer
There was no improvement in overall survival with bevacizumab.
Brigatinib Continues to Best Crizotinib in ALK+ Non-Small Cell Lung Cancer
There was an improvement in progression-free survival despite crossover.
