Genentech, a unit of Roche Holding AG (RHHBY), announced that the U.S. Food and Drug Administration has accepted its supplemental Biologics License Application (sBLA) for Lunsumio VELO as a subcutaneous formulation in combination with Polivy 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 decision on the application is scheduled for February 9, 2027.
The sBLA acceptance is based on results from the phase III SUNMO study.
SUNMO is a Phase 3, randomized, open-label, multicenter trial evaluating the efficacy and safety of the bispecific combination of Lunsumio VELO with intravenously administered polivy versus MabThera/Rituxan (rituximab) plus gemcitabine and oxaliplatin (R-GemOx) for relapsed or refractory LBCL with at least one prior systemic therapy who are ineligible for autologous stem cell transplant.
In the phase III SUNMO study, Lunsumio VELO plus Polivy demonstrated a 59% reduction in the risk of disease progression or death at a median follow-up of 23.2 months compared with Rituxan plus R-GemOx.
In addition, the company noted the combination achieved a median PFS of 11.5 months, more than three times longer than the 3.8 months for R-GemOx. Additionally, the safety profile of the combination was consistent with the known safety profiles of the individual medicines, said the company.
Large B-cell lymphomas (LBCLs) are a common type of non-Hodgkin lymphoma (NHL) that affect B lymphocytes and include diffuse large B-cell lymphoma (DLBCL), an aggressive form of the disease. According to the company, approximately 18,000 individuals are diagnosed with LBCL each year, with about 40% who experience relapse or refractory disease despite initial treatment responses.
Lunsumio VELO (mosunetuzumab-axgb) is a CD20xCD3 T-cell-engaging antibody administered as a subcutaneous formulation. It is designed to target CD20 on B-cells and CD3 on T-cell surfaces. Polivy is an anti-CD79b antibody-drug conjugate developed to treat several types of NHL.
RHHBY closed Wednesday's trade at $51.06, down 0.14% on the OTC Markets.
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