Lunsumio®▼
Lunsumio®▼ (mosunetuzumab), concentrate for solution for infusion (vial containing 1 mg or 30 mg of mosunetuzumab)
Swissmedic authorisation number: 68314
Swissmedic approval date: 9 February, 2023
Marketing authorisation studies (1)
Indication: Relapsed or refractory follicular lymphoma (FL)
Phase: II
Summary: Open-label, multicenter trial evaluating the safety and efficacy of mosunetuzumab monotherapy 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.
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. doi: 10.1016/S1470-2045(22)00335-7
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.
M-CH-00003297, 04/2026
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals and patients are asked to report any suspected adverse reactions. See our information for details on how to report.