FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

FDA Accepts Supplemental Biologics License Application for Genentech’s Lunsumio and Polivy Combination for People With Relapsed or Refractory Large B-Cell Lymphoma

– Filing acceptance based on data from the Phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death –

– People with relapsed or refractory LBCL represent one of the highest unmet need populations in lymphoma and require timely access to effective therapies –

– If approved, this outpatient-ready regimen could enable access to care in the community setting, where most U.S. patients receive treatment –

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous formulation, in combination with Polivy® (polatuzumab vedotin-piiq) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by February 9, 2027.