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