Keytruda Approved as Adjuvant Treatment for Stage IB, II, or IIIA NSCLC
The approval was based on data from the KEYNOTE-091 trial.
The approval was based on data from the KEYNOTE-091 trial.
The ready-to-dilute formulation was developed to eliminate the reconstitution step with Alimta.
The approval was based on data from the phase 3 ELUCIDATE study.
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
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.
The approval was based on data from a phase 3 POSEIDON study.
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
Alymsys is a vascular endothelial growth factor inhibitor.
Vegzelma is a vascular endothelial growth factor inhibitor.
The approvals were based on data from the LIBRETTO-001 trial.