FDA accepts sBLA for Genentech’s Lunsumio and Polivy combination in relapsed/refractory Large B-cell lymphoma

CAR-T Digest - August 2020

Weekly Digest - June 2026

17 June 2026: FDA Accepts sBLA for Genentech’s Lunsumio and Polivy combination in relapsed/refractory Large B-cell lymphoma

Genentech has announced that the U.S. FDA has accepted a supplemental Biologics License Application for Lunsumio in combination with Polivy for adults with relapsed or refractory Large B-cell lymphoma after at least one prior line of systemic therapy, advancing a potential new outpatient-ready treatment option for this high-unmet-need population
The filing was supported by results from the phase 3 SUNMO study, where Lunsumio VELO plus Polivy reduced the risk of disease progression or death by 59% versus R-GemOx (HR=0.41), achieving a median progression-free survival of 11.5 months compared with 3.8 months for the comparator regimen, while maintaining a manageable safety profile and low rates of cytokine release syndrome
If approved, the combination could provide an off-the-shelf, fixed-duration, chemotherapy-free immunotherapy-based regimen that can be administered in the community setting, potentially improving access to treatment for patients who are ineligible for or unable to undergo more intensive therapies
Polivy is a CD79b-directed antibody-drug conjugate that delivers the microtubule inhibitor MMAE to malignant B cells, while Lunsumio VELO is a subcutaneous CD20xCD3 T-cell-engaging bispecific antibody, creating a novel combination designed to enhance anti-lymphoma activity through complementary mechanisms of action
Strategically, the FDA acceptance further expands the commercial and clinical opportunities for Polivy beyond its existing indications, strengthens Roche/Genentech’s leadership in B-cell malignancies, and highlights the growing role of ADC-bispecific combinations as a next-generation treatment paradigm in relapsed or refractory lymphoma