Adagene Receives FDA Fast Track Designation for Muzastotug in Combination with KEYTRUDA for MSS mCRC Treatment.

Adagene Inc. announced that the FDA has designated muzastotug, in combination with Merck's KEYTRUDA, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer without liver metastases. The Fast Track Designation is supported by emerging clinical evidence demonstrating encouraging efficacy and a favorable safety profile. This designation enables more frequent FDA interactions and may allow for a rolling review of future marketing applications as Adagene continues the ongoing randomized Phase 2 and prepares for the registration trial.