The BCL-2 inhibitor was granted accelerated approval based on findings from the phase 1/2 BGB-11417-201 study.

Mantle cell lymphoma is a rare, aggressive form of non-Hodgkin lymphoma that affects roughly 3,300 new patients annually in the United States. ・Continued approval will depend on confirmatory trials, ...

Accelerated approval of sonrotoclax establishes a targeted BCL2 option in post–BTK inhibitor relapsed/refractory mantle cell lymphoma, a setting with limited effective salvage therapies and poor ...

Beqalzi (sonrotoclax) is the first BCL2 inhibitor indicated for MCL patients who have progressed after at least 2 lines of therapy, including a BTK inhibitor.

By Siddhi Mahatole and Puyaan Singh May 13 (Reuters) - BeOne Medicines said on Wednesday that the U.S. Food and Drug ...

The FDA has granted accelerated approval to Beqalzi (sonrotoclax), the first BCL2 inhibitor approved for adults with relapsed or refractory mantle cell lymphoma (MCL), an aggressive form ...

The FDA granted accelerated approval to sonrotoclax (Beqalzi) as the first BCL2 inhibitor for relapsed or refractory mantle ...

Accelerated approval covers post–BTK inhibitor relapsed/refractory MCL, making sonrotoclax the only BCL2 inhibitor specifically approved for this indication. Independent Lugano-assessed efficacy in ...

BEQALZI™ (sonrotoclax) is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, ...

FDA accelerated approval covers relapsed/refractory MCL after ≥2 lines including a BTK inhibitor, positioning sonrotoclax as a potential first-in-class BCL-2 option in this setting. Single-arm ...

BeOne Medicines has entered the BCL-2 arena, securing an FDA green light for Beqalzi that carves out a unique piece of territory ahead of a potential broader clash with market leader Venclexta. The ...

The study covers the period of 2015-2019 in Germany, before approvals for CAR T-cell therapy, pirtobrutinib, and the arrival of less toxic BTK inhibitors. UK real-world data show that bridging therapy ...