Roche (RHHBY,RO.SW,ROG.SW) announced the FDA has accepted the company's supplemental Biologics License Application 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, including diffuse large B-cell lymphoma, after at least one prior line of systemic therapy. The FDA is expected to make a decision on approval by 9 February 2027. The sBLA acceptance is based on results from the phase III SUNMO study.
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. Lunsumio is part of Roche's CD20xCD3 bispecific antibody programme.
At last close, Roche shares were trading at 327.80 Swiss francs, up 1.17%.
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