Drugs in the Pipeline
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.
Your search for non small cell lung cancer returned 36 results
Drugs in the Pipeline
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.
News
Libtayo Cleared for Frontline Use in Advanced NSCLC With High PD-L1 Expression
The approval is based on data from the randomized, open-label phase 3 EMPOWER-Lung1 trial.
Drugs in the Pipeline
Trastuzumab Deruxtecan Gets Priority Review for Previously Treated HER2-Mutant Metastatic NSCLC
The sBLA is supported by data from the phase 2 DESTINY-Lung01 trial, along with a phase 1 trial published in Cancer Discovery.
Drugs in the Pipeline
Atezolizumab Gets Priority Review as Adjuvant Treatment for Early NSCLC
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 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.
Drugs in the Pipeline
Trial Investigating Canakinumab for Advanced or Metastatic NSCLC Misses Primary End Point
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to interleukin-1beta.
News
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.
Drugs in the Pipeline
No Added Benefit With Pembrolizumab Combo vs Monotherapy for Metastic NSCLC
Results showed the median OS was 21.4 months in the pembrolizumab plus ipilimumab arm compared with 21.9 months in the pembrolizumab monotherapy arm.
News
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…
