Basel, 6 July 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for Lunsumio® (mosunetuzumab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. FL is the most common indolent (slow growing) form of non-Hodgkin lymphoma (NHL), a type of blood cancer, which often returns after initial therapy. The FDA is expected to make a decision on approval of this novel cancer immunotherapy by 29 December 2022.
Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. The FDA granted Breakthrough Therapy designation (BTD) to Lunsumio for the treatment of adults with R/R FL who have received at least two prior systemic therapies in June 2020 and Orphan Drug Designation in December 2018. BTD is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate substantial improvement over existing therapies. The European Commission granted conditional marketing authorisation for Lunsumio for the treatment of people with R/R FL who have received at least two prior systemic therapies in June 2022.
About Lunsumio® (mosunetuzumab)
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. This 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. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other blood cancers.