Shots:

• The US FDA has approved Rezlidhia for patients with r/r AML with a susceptible IDH1 mutation
• The approval was based on the P-II study evaluating Rezlidhia (150mg, BID) as monothx. in 153 patients which showed that patients achieved a 35% CR+CRh rate with an m-DoR of 25.9mos., the median time to CR or CRh was 1.9mos. Among patients who achieved the 1EPs of CR+CRh, 92% were CR with an m-DoR of 28.1mos.
• The therapy was well tolerated, 16% reported differentiation syndrome & which was manageable with dose interruption & corticosteroids. Under Aug 2022 collaboration with Forma, Rigel will be responsible to launch & commercialize Rezlidhia in the US & is planning to work with partners for developing & commercializing the product outside the US

Ref: Rigel | Image: Rigel