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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.

Gavreto is an oral tyrosine kinase inhibitor.

Pemrydi RTU is expected to be available in the first quarter of 2024.

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.