Roche’s Lunsumio VELO–Polivy combo moves closer to FDA decision after strong lymphoma trial results
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines
The approval is supported by results from the Phase 3 SWOG 1826 trial
The investigational therapy, MDX2003, is designed to go after cancer cells with a multi-pronged immune attack
These approvals represent a defining moment for people living with classical Hodgkin Lymphoma
The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma
PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma
Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide
Full approval will depend on verification of clinical benefit in a confirmatory trial
The FDA aims to make a decision by April 8, 2026
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