Cancer, Blood cancer, Diffuse large B cell lymphoma
RHHBYRoche HoldingCatalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Lunsumio + Polivy in Cancer, Blood cancer, Diffuse large B cell lymphoma. The expected timing is based on the latest available company guidance and may change.
STARGLO trial.4/15/24- Met primary endpoint of overall survival. Submit data to health authorities and present at upcoming medical meeting. 05/19/26:- SUNMO updated data for Lunsumio plus Polivy 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.