The FDA granted approval to Brukinsa (zanubrutinib) capsules, developed by Beijing-based biotechnology company BeiGene, for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, the administration said in a press release.
"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," the FDA quoted 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, as saying.
"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.
In a single-arm clinical trial including 86 patients with mantle cell lymphoma who had received at least one prior treatment, 84 percent of patients had tumor shrinkage with a median duration of response of 19.5 months, the FDA said.
This trial was supported by an additional single-arm trial that included 32 patients, in which 84 percent of patients had tumor shrinkage with a median duration of response of 18.5 months, the FDA added.
"Today we have a new option for our adult patients who have received one prior systemic or targeted therapy and are living with MCL, an aggressive blood cancer that's often diagnosed at a more advanced stage," Wang Luhua, a professor of the University of Texas MD Anderson Cancer Center, and Brukinsa's clinical trial investigator, said in a statement.