FDA approves breakthrough lymphoma treatment

The FDA approved Nov. 14 BeiGene USA's drug, Brukinsa, designed to treat adult patients with mantle cell lymphoma who have received at least one prior therapy.

Mantle cell lymphoma represents 3 percent to 10 percent of all non-Hodgkin's lymphomas in the U.S.

Clinical trials for Brukinsa showed 84 percent of patients saw tumor shrinkage after treatment.

Common side effects of Brukinsa include decreased neutrophil count, decreased platelet count, upper respiratory tract infection and decreased white blood cell count.

During treatment, patients should be monitored for hemorrhage, signs and symptoms of infection, cytopenias and cardiac arrhythmias.

Patients are also advised to use sun protection because of the risk for skin cancers.

Women who are pregnant or breastfeeding should not take Brukinsa because it could cause harm to a developing fetus or newborn baby.

The FDA granted Brukinsa accelerated approval, breakthrough therapy designation and orphan drug designation.

Read the full news release here.

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