BRIEF—Chugai Files NDA in Japan for mosunetuzumab

Japanese drugmaker Chugai Pharmaceuticals has filed regulatory applications with the Ministry of Health, Labor and Welfare (MHLW) for the anti-CD20xCD3 bispecific antibody mosunetuzumab for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior systemic therapies.

“Mosunetuzumab has shown promising results in clinical trials as monotherapy for achieving durable remissions. In addition, unlike previous treatments that require long-term continuous administration and hospitalization, the treatment period is predetermined, so it is expected to reduce the burden of hospital visits associated with treatment. We will continue working with the authorities to deliver this drug, which has the potential to change patients’ prognosis and social life, for patients as quickly as possible,” said Dr Osamu Okuda, president and chief executive of Chugai, which is majority owned by Swiss pharma giant Roche.

The application is based on the results of the Japanese Phase I study and overseas Phase I/II study conducted by Roche in patients with R/R FL who had previously received two or more prior systemic therapies.