The approval was based on the P-III (AGILE) study evaluating Tibovo + azacitidine vs PBO + azacitidine in adults (≥75yrs.) with formerly untreated IDH1-mutated AML incl. those who are not candidates for intensive CT or have comorbidities that preclude the use of intensive induction CT
The results showed a significant improvement in EFS (HR=0.35), OS (HR=0.44) & a three-fold improvement in mOS of Tibsovo + azacitidine (24mos.) vs PBO + azacitidine (7.9mos)
Tibsovo (500mg, oral, QD) was approved in the US as a monothx. for IDH1-mutant r/r AML & IDH1-mutant AML. The company has launched ServierONE Patient Support Services to help patients who are prescribed Tibsovo/other Servier products, navigate their cancer journey
Ref: PRNewswire | Image: Servier
