FDA Approves Brukinsa for Patients with Relapsed and Refractory Mantle Cell Lymphoma

November 15, 2019

The Food and Drug Administration has approved Brukinsa to treat patients with mantle cell lymphoma whose disease has stopped responding to other medications or has recurred.

The Food and Drug Administration (FDA) approved Brukinsa (zanubrutinib), a new drug for the treatment of the blood cancer mantle cell lymphoma (MCL).

The oral medication is approved to treat patients with MCL whose disease has stopped responding to other medications or has recurred. In a clinical trial that included 86 patients, 84% who took the drug experienced tumor shrinkage that lasted a median of 18.5 months.

While mantle cell lymphoma, a type of non-Hodgkin lymphoma, usually responds well to initial treatment, it eventually returns or stops responding, and Brukinsa will provide another medical option in such cases, said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the agency’s Center for Drug Evaluation and Research.

Brukinsa is a targeted drug known as a kinase inhibitor. Its side effects include blood count problems, rash, diarrhea and cough.

The drug was granted accelerated approval by the FDA because it will fill an unmet need for people with a serious condition.

Check back later to learn more about how this approval will affect patients with MCL.


x