FDA Grants Priority Review to Roche’s Lunsumio for Follicular Lymphoma
The FDA has accepted Roche’s Biologics License Application (BLA) for Lunsumio (mosunetuzumab) and has granted the drug a priority review for treatment of adult patients with relapsed or refractory follicular lymphoma who received at least two prior systemic therapies.
Roche supported the application with positive results from a pivotal phase 1/2 study showing Lunsumio induced “high and durable complete response rates” in people with follicular lymphoma who received two or more prior therapies.
The FDA is expected to make a decision on the BLA by Dec. 29. The drug has already received a conditional marketing authorization in the EU for the same indication.