Shots:

• The approval is based on the P-II (GVHD-1) trial to evaluate Orencia + CNI and MTX vs PBO + CNI and MTX in adults and pediatric patients aged ≥2yrs. for the prevention of aGvHD in patients who undergoes HSCT from a matched or 1 allele-mismatched URD
• In the GVHD-1 trial, abatacept showed an improved severe (grade III-IV) aGvHD-free survival in 7/8 mismatched unrelated donor transplant and associated mortality. In the 8/8 HLA-matched cohort, grade III-IV & grade II-IV aGvHD-free survival was (87% vs 75%) & (50% vs 32%) respectively
• Orencia is a selective costimulation modulator that disrupts the continuous cycle of T-cell activation & the approval marks the 4th indication for Orencia

Ref: BMS | Image: BMS