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Sonrotoclax granted breakthrough therapy designation by the FDA for R/R MCL
On October 13, 2025, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to sonrotoclax, a next-generation B-cell lymphoma 2 (BCL-2) inhibitor, for the treatment of adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL).1 Additionally, sonrotoclax will be included in Project Orbis, a framework for concurrent submission and review of oncology products among participating global health authorities.1
These decisions were based on results from the phase I/II BGB-11417-201 trial (NCT05471843), evaluating sonrotoclax in adult patients with R/R MCL, following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy.1 Full data from this trial are expected to be presented at an upcoming medical meeting.1
Results from the ongoing phase I/Ib BGB-11417-101 trial (NCT04277637) assessing the safety and efficacy of sonrotoclax + zanubrutinib in patients with R/R MCL, presented at the European Hematology Association (EHA) 2025 Congress, June 12–15, 2025, Milan, IT, by Raul Cordoba, were previously reported by the Lymphoma Hub. Briefly, the overall response rate (ORR) and complete response (CR) rate were 78% and 70%, respectively, with a 24-month duration of response (DoR) rate of 80.1%.2 Sonrotoclax + zanubrutinib had a tolerable safety profile, with no dose-limiting toxicities (DLTs).2 The confirmatory phase III CELESTIAL-RRMCL trial (NCT06742996) is underway, with enrollment ongoing.1,2
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