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.
Lung Cancer
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.
October 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in October 2022 for investigational products in development.
Statin Use May Reduce Risk for Lung Cancer in Patients With IPF
A study was conducted to assess if statin use in patients with IPF can prevent development of lung cancer.
Bevacizumab Biosimilar Alymsys Now Available
Alymsys is a vascular endothelial growth factor inhibitor.
Sapanisertib Fast Tracked for NRF2-Mutated Squamous NSCLC
Sapanisertib is a dual mTORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells.
Bevacizumab Biosimilar Vegzelma Gets FDA Approval
Vegzelma is a vascular endothelial growth factor inhibitor.
Enhertu Gets Accelerated Approval for HER2-Mutant Metastatic NSCLC
The accelerated approval was based on data from the phase 2 DESTINY-Lung02 trial that included adults with HER2-mutant metastatic NSCLC after 1 prior systemic therapy.
Tabrecta Granted Full Approval for Metastatic NSCLC Based on Confirmatory Data
The full approval was based on data from an additional 63 adults with metastatic NSCLC with confirmed MET exon 14 skipping as well as 22 months of follow-up time.
