FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

The U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

Common side effects for patients taking Brukinsa were decreased neutrophil count (white blood cells that fight against infection), decreased platelet count (a component of blood whose function is to react to bleeding from blood vessel injury by clumping, initiating a blood clot), upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin (oxygen-carrying protein in red blood cells), rash, bruising, diarrhea and cough. During treatment, patients should be monitored for hemorrhage (bleeding), signs and symptoms of infection, cytopenias (decreased complete blood counts) and cardiac arrhythmias (irregular, rapid heart rate and abnormality in beating of the heart). Patients are advised to use sun protection if taking this therapy because there is a risk of other malignancies occurring including skin cancers. The FDA advises health care professionals to tell females of reproductive age and males with a female partner of reproductive potential to use effective contraception during treatment with Brukinsa. Women who are pregnant or breastfeeding should not take Brukinsa because it may cause harm to a developing fetus or newborn baby.

For more information, please visit: Brukinsa.