The FDA ( Food and Drug Administration ) has granted accelerated approval to Calquence ( Acalabrutinib ) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.
Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute ( NCI ) at the National Institutes of Health ( NIH ), represents 3 to 10% of all non-Hodgkin lymphoma cases in the U.S.
Mantle cell lymphoma is a cancer of the lymph system, which is part of the body’s immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow.
By the time mantle cell lymphoma is diagnosed, it usually has spread to the lymph nodes, bone marrow and other organs.
Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread.
Calquence was approved using the Accelerated Approval pathway, under which the FDA may approve drugs for serious conditions where there is unmet medical need and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients.
Further study is required to verify and describe anticipated clinical benefits of Calquence and the sponsor is currently conducting this trial.
The approval of Calquence was based on data from a single-arm trial that included 124 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, 81% of patients had a complete or partial response ( 40% complete response, 41% partial response ).
Common side effects of Calquence include headache; diarrhea; bruising; fatigue and muscle pain ( myalgia ); and anemia, thrombocytopenia and neutropenia in the blood.
Serious side effects include bleeding, infections and atrial fibrillation.
Additional cancers, known as second primary malignancies, have occurred in some patients taking Calquence.
Women who are breastfeeding should not take Calquence because it may cause harm to a newborn baby. ( Xagena )
Source: FDA, 2017