FDA green light for Genentech's Lunsumio

Ahead of the expected December 29 action date, and adding to European approval in June, the US Food and Drug Administration (FDA) yesterday granted marketing authorization for Swiss pharma giant Roche (ROG: SIX) subsidiary Genentech’s Lunsumio (mosunetuzumab-axgb), for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate, making Lunsumio the first CD20xCD3 bispecific to be authorized for this form of non-Hodgkin lymphoma (NHL). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Genetech says that Lunsumio will be available in the USA in the coming weeks.