Servier Reports the US FDA Acceptance of sNDA and Granted Priority Review of Tibsovo (ivosidenib) for R/R Myelodysplastic Syndromes
Shots:
- The sNDA was based on the P-I open-label study evaluating Tibsovo, showed durable remissions incl. complete response in nearly 40% of patients, and an acceptable safety profile while CR rate of 38.9% and ORR of 83.3% in the efficacy analysis set & the median time to CR was 1.87mos.
- The median duration of CR (not reached) & m-OS (35.7mos.), 66.7% became independent of transfusions during any ≥56-day post-baseline period among nine patients who were transfusion dependent with red blood cells or platelets at baseline, TRAEs were consistent with the known safety profile of Tibsovo with no new safety signals
- Tibsovo was approved in the US as a monotx. for adults with IDH1-mutant r/r AML and in monotx. or in combination with azacitidine for IDH1-mutant AML aged ≥75yrs.
Ref: PRNewswire | Image: Servier
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