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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.

A regulatory decision is expected on November 27, 2023.

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.

Sapanisertib is a dual mTORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells.