Relapsed Or Refractory Large B-Cell Lymphoma
RHHBYRoche HoldingCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Lunsumio VELO/Mosunetuzumab + Polivy (CD20xCD3 Bispecific) in Relapsed Or Refractory Large B-Cell Lymphoma. The expected timing is based on the latest available company guidance and may change.
12/22/25:- SUNMO Phase 3 trial of Lunsumio VELO plus Polivy in 2L+ large B-cell lymphoma is ongoing. 02/07/26:- Subcutaneous Lunsumio plus Polivy showed outpatient, chemotherapy-free potential in relapsed or refractory large B-cell lymphoma in SUNMO. 05/19/26:- SUNMO updated efficacy and safety to be presented at ASCO May 30, 2026. 06/18/26:- FDA accepted SUNMO sBLA; decision expected February 9, 2027. 07/23/26:- SUNMO sBLA acceptance was reiterated; FDA decision will occur February 9, 2027.
Verification
Confirm timing and program details against the company announcement or filing.