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Cancer patients with biomarker-positive tumors have better outcomes on immune checkpoint inhibitor therapy, a meta-analysis suggests.

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.

A regulatory decision is expected on November 27, 2023.

Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody.

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.