Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody.
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The designation is supported by data from the ongoing phase 2 KEYNOTE-942 study, which included 157 patients with stage III/IV melanoma following complete resection.
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.
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.
Sapanisertib is a dual mTORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells.