BeiGene USA gets FDA nod for Brukinsa

BeiGene USA has received the Food and Drug Administration’s clearance for Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

“Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This is a life-threatening condition,” said Richard Pazdur, director of the FDA’s oncology center of excellence and acting director of the office of oncologic diseases in the FDA’s Center for Drug Evaluation and Research.

“Clinical trials showed that 84% of patients saw tumor shrinkage with this therapy. For patients whose disease relapses or becomes refractory, secondary therapies may be successful in providing another remission, and today’s approval will provide patients with another treatment option,” said Pazdur.

Mantle cell lymphoma is a type of non-Hodgkin’s lymphoma representing 3%-10% of all non-Hodgkin’s lymphomas in the United States. By the time it is diagnosed, mantle cell lymphoma has usually spread to the lymph nodes, bone marrow and other organs. In relapsed lymphoma, the disease reappears or grows again after a period of remission, while in refractory lymphoma, the disease does not respond to treatment or responds only briefly.