The FDA ( U.S. Food and Drug Administration ) has 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.
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.
A single-arm clinical trial of Brukinsa included 86 patients with mantle cell lymphoma who had received at least one prior treatment.
The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment ( overall response rate ).
In the trial, 84% of patients had tumor shrinkage with a median duration of response ( time between the initial response to therapy and subsequent disease progression or relapse ) of 19.5 months.
This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 months.
Common side effects for patients taking Brukinsa were decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea and cough.
During treatment, patients should be monitored for hemorrhage, signs and symptoms of infection, cytopenias and cardiac arrhythmias.
Patients are advised to use sun protection if taking this therapy because there is a risk of other malignancies occurring including skin cancers.
Females of reproductive age and males with a female partner of reproductive potential should 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.
Brukinsa was granted Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients.
The FDA granted this application Breakthrough Therapy designation, which expedites the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies.
Brukinsa has also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. ( Xagena )
Source: FDA, 2019