Posted by Michael Wonder on 27 Nov 2025
US FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma
26 November 2025 - BeOne Medicines today announced that the US FDA has accepted and granted priority review to a new drug application for sonrotoclax, a next generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, following treatment with a relapsed or refractory mantle cell lymphoma inhibitor.
The new drug application is supported by data from the global, multi-centre, single-arm, open-label, Phase 1/2 study, BGB-11417-201 which enrolled 125 adult patients with relapsed or refractory mantle cell lymphoma who received prior treatment with a Bruton's tyrosine kinase inhibitor.
