Genentech’s Lunsumio OK’d for Some Lymphomas

FDA has approved Genentech’s Lunsumio (mosunetuzumab-axgb), described as a first-in-class bispecific antibody, to treat patients with relapsed or refractory follicular lymphoma. The company says that results from a pivotal Phase 2 trial demonstrated that 80% of patients who received at least two prior therapies achieved durable response rates, with 60% experiencing complete remission.

The indication was approved, Genentech says, under accelerated approval based on response rate. “Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” the company says.

The company says Lunsumio is designed to address the diverse needs of people with blood cancer. It is being further investigated as a subcutaneous formulation and in Phase 3 studies that will expand the understanding of its impact in earlier lines of treatment in people with non-Hodgkin’s lymphoma.