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.
Cemiplimab Offers Chemo-Free First-Line Option for Advanced NSCLC
First-line cemiplimab can improve long-term survival outcomes, compared with chemotherapy, in advanced non-small cell lung cancer.
Many Patients With Advanced NSCLC Do Not Survive Beyond First-Line Therapy
Many patients with advanced non-small cell lung cancer do not survive long enough to receive second-line therapy, a real-world study suggests.
Earlier Detection of Non-Small Cell Lung Cancer Needed for Younger Patients
Advanced disease at diagnosis is more likely among younger patients with non-small cell lung cancer, according to a new study.
Novel Immunotherapy Combos Show Promise in Stage III Non-Small Cell Lung Cancer
Combining either oleclumab or monalizumab with durvalumab provided a progression-free survival benefit over durvalumab alone.
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.
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