News
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
News
The approval was based on data from the KEYNOTE-091 trial.
News
The approval was based on data from a phase 3 POSEIDON study.
Drugs in the Pipeline
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.
News
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
News
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.
News
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.
News
Alymsys is a vascular endothelial growth factor inhibitor.
News
The ready-to-dilute formulation was developed to eliminate the reconstitution step with Alimta.
Drugs in the Pipeline
Sapanisertib is a dual mTORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells.
