Swissmedic authorisation number: 68314
Swissmedic approval date: february 9th, 2023
Indication: Relapsed or refractory follicular lymphoma (FL)
Summary: Open-label, multicenter trial evaluating the safety and efficacy of mosunetuzumab as a single agent in patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic lines of therapy, including a monoclonal anti-CD20 antibody and an alkylating agent.
After a median follow-up of 18.3 months, the median duration of response among responders was 22.8 months (95% CI: 18.7-not estimable), the complete response rate was 60% (n=54/90), the objective response rate was 80% (n=72/90). The most common adverse event was cytokine release syndrome (44%), which was generally low grade (grade 3-4: 2%). All events of cytokine release syndrome resolved. Other common (≥10%) adverse events were neutropenia, pyrexia, fatigue, hypophosphatemia and headache.
Results were published in Budde et al., Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1055-1065.
Sponsor: Genentech, Inc
Publication of the results of clinical trials
The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorisation for Lunsumio. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorisation by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.
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