Also known as Polivy.
Phase III CELESTIMO interim analysis showed a statistically significant, clinically meaningful PFS benefit versus rituximab+lenalidomide; OS immature; safety consistent with known profiles.
Phase III CELESTIMO showed a statistically significant, clinically meaningful progression‑free survival benefit for Lunsumio plus lenalidomide versus rituximab plus lenalidomide in relapsed/refractory FL after ≥1 prior therapy.
sBLA accepted based on phase III SUNMO showing 59% reduction in progression risk; FDA decision expected by 9 Feb 2027.
sBLA accepted for subcutaneous bispecific + ADC combo in relapsed/refractory large B‑cell lymphoma; FDA decision expected Feb 9, 2027.
Core rev ¥321.7B (+11.5%), core OP ¥163.3B (+17.1%), core net ¥118.6B (+19.6%). Launched Elevidys (DMD JP); Lunsumio+Polivy approved for LBCL. R&D: NXT007 switch, Enspryng (MOGAD), Foundayo US approval.
Japan approves Lunsumio + Polivy for relapsed/refractory large B‑cell lymphoma after Phase III SUNMO: ORR 69.7%, PFS 11.5 vs 3.8 months (59% lower progression/death risk); manageable safety.
