BeOne has secured accelerated approval in the US for its next-generation BCL2 inhibitor, Beqalzi (sonrotoclax), for the treatment of relapsed or refractory mantle cell lymphoma (MCL). The approval is specifically for adult patients who have received at least two prior lines of systemic therapy, including a BTK inhibitor. This marks the first novel BCL2 inhibitor approved in the US in a decade for this indication.

The approval was based on data from the Phase I/II BGB-11417-201 study, which demonstrated an objective response rate (ORR) of 52% and a complete response rate (CRR) of 16% in this heavily pre-treated population. The median duration of response was 15.8 months. Sonrotoclax, which has a short half-life and is designed to minimise drug accumulation, offers a new treatment option for patients with this aggressive form of non-Hodgkin's lymphoma (NHL).

According to PharmCube's NextBiopharm® database, Beqalzi is the third BCL2-targeted drug to obtain regulatory approval globally. Click here to request a free trial for NextBiopharm®.