FDA Approves Novel Therapies for Lymphoma Indications

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IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. 

Accelerated approval of acalabrutinib 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 overall response rate, and 81% of patients enrolled had a complete or partial response. Common side effects of acalabrutinib include headache, diarrhea, bruising, fatigue, myalgia, anemia, thrombocytopenia, and neutropenia. Serious side effects include hemorrhage, infections, and atrial fibrillation. Second primary malignancies have occurred in some patients taking acalabrutinib. 

Axicabtagene ciloleucel is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma. The CAR T-cell therapy is approved for use in adult patients with lymphomas including diffuse large B-cell lymphoma -(DLBCL), primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. The safety and efficacy of axicabtagene ciloleucel were established in a multicenter clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment with axicabtagene ciloleucel was 51%.

Treatment with axicabtagene ciloleucel has the potential to cause severe side effects. It carries a boxed warning for cytokine-release syndrome. The FDA is requiring that hospitals and their associated clinics that dispense axicabtagene ciloleucel be specially certified. ■




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