December 23, 2022
1 min read
The FDA granted accelerated approval to mosunetuzumab-axgb for treatment of adults with relapsed or refractory follicular lymphoma, the agency announced in a press release.
Mosunetuzumab-axgb (Lunsumio, Genentech), a bispecific CD20/CD3 antibody, was approved for use in adults who received at least two prior systemic therapies. As Healio previously reported, mosunetuzumab received FDA priority review in July 2022.
This accelerated approval is based, in part, on results from an open-label, multicenter, multi-cohort study that evaluated 90 patients with relapsed or refractory follicular lymphoma who received two or more prior therapies. Objective response rate (ORR) served as the primary endpoint.
After a median follow-up of 14.9 months, researchers reported an 80% ORR (95% CI, 70-88) and a 60% complete response rate. Median duration of response was 22.8 months, with more than half of participants maintaining their responses at 12 months (62%) and 18 months (57%), the release stated.
The most common adverse events that occurred among more than 20% of study participants with hematologic malignancies (n = 218) were cytokine release syndrome (CRS; 39%), fatigue, rash, pyrexia and headache. Most cases of CRS were low grade (grade 2, 15%; grade 3, 2%; grade 4, 0.5%).
According to the release, the drug should be given at specified doses to qualifying patients for eight cycles, each of which is 21 days.
“This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” Elizabeth Budde, MD, PhD, hematologic oncologist and associate professor at City of Hope and clinical trial investigator for mosunetuzumab, said in a Genentech-issued press release. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”