Summary
BeOne Medicines received accelerated approval for sonrotoclax (BEQALZI) to treat adults with relapsed or refractory mantle cell lymphoma (MCL) who have failed at least two prior therapies, including a BTK inhibitor.
Backed by Phase 1/2 trial data in 103 heavily pre-treated patients, the drug distinguishes itself from the existing standard, AbbVie/Roche's venetoclax (VENCLEXTA), through claimed 14x greater potency, higher BCL2 selectivity, and a shorter half-life that simplifies dosing and reduces tumor lysis syndrome monitoring burdens.
A decade after the last BCL2 inhibitor won FDA approval, a next-generation challenger has arrived. In May 2026, th...
