BeOne’s sonrotoclax granted FDA Breakthrough Therapy designation

Sino-American oncology specialist BeOne Medicines (Nasdaq: ONC; SHA: 688235) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for sonrotoclax, a potentially best-in-class investigational BCL2 inhibitor, for the treatment of relapsed or refractory (R/R) mantle cell lymphoma (MCL).

The FDA has also accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

The next major advancement in BeOne’s commitment to redefining care in B-cell malignancies