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Steven Stein, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion in favor of granting conditional marketing authorization to the combination of tafasitamab-cxix and lenalidomide, followed by single-agent tafasitamab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.

Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program Senior Physician at Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School,

The majority of patients with indolent follicular lymphoma do well with observation and after first-line treatment, but approximately 20% experience disease progression within 2 years of their initial treatment, which is associated with a 50% risk of dying within 5 years. Subsequently, this is an area of unmet need but one in which considerable progress is being made.

In the first few years of their availability in the United States, axicabtagene ciloleucel and tisagenlecleucel have been used to mostly treat patients with diffuse large b-cell lymphoma in the outpatient setting who are receiving the CAR T-cell therapies prior to failure on 2 prior lines of therapy.