Roche Receives FDA Regular Approval for Lunsumio in Follicular Lymphoma

Roche today announced that the FDA has granted regular approval to Lunsumio (mosunetuzumab-axgb) for adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. This regular approval converts the prior accelerated approval of Lunsumio and is based on updated data from the GO29781 trial showing durable responses. The updated data showed a complete response rate of 60% with a median duration of complete response of 37.4 months. These results confirm the durable clinical benefit of Lunsumio in relapsed or refractory FL.