EMA Recommends Conditional Approval of Mosunetuzumab for Follicular Lymphoma

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended the conditional approval of mosunetuzumab for the treatment of relapsed/refractory FL in patients who have received at least two prior systemic therapies.

The recommendation was based on results from the multicenter, open-label, dose-escalation/expansion, phase I/II GO29781 study that included patients with relapsed/refractory non-Hodgkin lymphoma (NHL). After a median follow-up of 18.3 months, the CR rate was 60% (n=54/90), the ORR was 80% (n=72/90), and median progression-free survival was 17.9 months (95% CI, 10.1-not estimable). The median duration of response among responders was 22.8 months (95% CI, 9.7-not estimable).

The most common adverse event associated with mosunetuzumab was CRS (44.4%).

Mosunetuzumab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T cells. A final decision regarding the conditional approval is expected soon from the European Commission.

Conditional marketing authorization is granted to products that fulfill an unmet need and when benefits outweigh risks. Additional follow-up data are required for these products to obtain official approval.

Sources: European Medicines Agency release, April 2022; Roche media release, April 2022