Chugai gains Japanese regulatory approval for Lunsumio

Japanese drugmaker Chugai Pharmaceuticals (TYO: 4519) has obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for Lunsumio (mosunetuzumab) for intravenous infusion 1mg and 30mg for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior standard therapies.

Lunsumio is a T-cell engaging bispecific antibody targeting CD20/CD3, offering a new treatment option with high response rates and the potential for durable remission. The treatment duration is set at approximately six months or one year, depending on the patient’s response to treatment, noted Chugai, which is majority-owned by Swiss pharma giant Roche (ROG: SIX).

“R/R FL is a difficult-to-cure disease that repeatedly relapses, and there is a need for new treatment options. Lunsumio is expected to provide durable remission with monotherapy, and with a predetermined treatment duration based on each patient’s response to therapy, which can help reduce the burden of treatment on patients. We are proceeding with preparations for the launch to make this drug available for treatment as soon as possible,” said Dr Osamu Okuda, Chugai’s president and chief executive.