BeOne Medicines Secures FDA Breakthrough Therapy Designation for Sonrotoclax in Treating Mantle Cell Lymphoma,

FDA OKs Breakthrough Therapy Designation to Sonrotoclax for MCL

The FDA granted breakthrough therapy designation to sonrotoclax for adults with relapsed or refractory mantle cell lymphoma, based on phase 1/2 data.

US FDA grants BeOne’s sonrotoclax breakthrough designation for MCL

The FDA has also approved BeOne’s application to participate in Project Orbis, an initiative that offers a framework for concurrent submission and oncology products review among collaborating health The post US FDA grants BeOne’s sonrotoclax breakthrough designation for MCL appeared first on Pharmaceutical Business review.

BeOne Medicines Secures FDA Breakthrough Therapy Designation for Sonrotoclax in Treating Mantle Cell Lymphoma,

'SAN CARLOS, Calif. '' BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a pioneering global oncology company, has announced a significant milestone in its clinical development programme. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, an advanced and potentially best-in-class investigational BCL2 inhibitor. This designation is aimed at improving treatment options for ad…