Roche wins first approval for bispecific blood cancer drug

June 8, 2022

Roche announced that the European Commission gave conditional approval to the drugmaker's bispecific lymphoma drug, Lunsumio, to treat patients who’ve already tried other therapies. 

The nod makes Lunsumio the first CD20xCD3 bispecific antibody approved anywhere. The first-in-class drug is designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. The dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells.

The green light was supported by positive data from the GO29781 study, a phase 1/2 expansion study evaluating the safety and efficacy of the drug in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study found that the majority of patients had high complete response rates, with the majority of responses lasting at least 18 months, and favorable tolerability.

The drug is expected to compete with CAR T-cell therapies, as the immunotherapeutic approach doesn’t require patients to wait before starting treatment.

“We are delighted that Lunsumio is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma,” said Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of Global Product Development. “Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated.”