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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 sBLA was supported by data from the phase 3 TOPAZ-1 trial.

Sintilimab is an investigational programmed death receptor-1 (PD-1) inhibitor.

The decision was made to withdraw the application after the Companies and the FDA were not able to align on certain postmarketing studies.

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.