Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), said on Thursday that the US Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application for subcutaneous Lunsumio VELO (mosunetuzumab-axgb) in combination with Polivy (polatuzumab vedotin-piiq) for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least one prior systemic therapy.

The FDA is expected to make an approval decision by 9 February 2027.

The filing is supported by data from the Phase III SUNMO study, in which the Lunsumio VELO and Polivy combination reduced the risk of disease progression or death by 59% versus Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx), and delivered median progression-free survival of 11.5 months compared with 3.8 months for the comparator regimen.

At a median follow-up of 23.2 months, the combination maintained a safety profile consistent with the individual medicines, while cytokine release syndrome occurred in approximately one-quarter of patients and Grade 2 or 3 events were reported in fewer than 5% of patients.

Updated results presented at recent oncology and haematology conferences showed continued progression-free survival benefit with longer follow-up and no new safety signals.

Genentech said the outpatient-ready regimen could expand access to treatment in community settings, where most US patients receive care.