
- August 2020
- Volume 26
- Issue 7
Tafasitamab Combination Approved for Adults With R/R DLBCL
A new treatment option is approved for patients with a common form of non-Hodgkin lymphoma who cannot have an autologous stem cell transplant.
On July 31, FDA approved tafasitamab-cxix to be used in combination with lenalidomide for second-line treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), meeting the needs of patients who are not eligible for an autologous stem cell transplant.
Tafasitamab, to be sold as Monjuvi by MorphoSys and Incyte, is a humanized Fc-modified cytolytic CD19 monoclonal antibody being studied in several B-cell malignancies. As described in the journal
Approval was based on phase 2 results for 80 patients in the
Among non-Hodgkin lymphomas, DLBCL is the most common subtype, accounting for 22% of cases in the United States and 40% worldwide, with about 18,000 US cases per year. People are at higher risk if they have HIV, an autoimmune disease, or if they have had an organ transplant. More common in older people, DLBCL can be very aggressive. Although well-known treatments have been developed, there are gaps—and a notable one is when DLBCL cannot be kept in remission after chemotherapy but the patient is not eligible for an autologous stem cell transplant. Some of these patients have had chimeric antigen receptor (CAR) T-cell therapy, but this process is costly with significant side effects.
“The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States,” Hervé Hoppenot, CEO of Incyte, said
FDA had previously granted the combination Fast Track and Breakthrough Therapy Designation in this indication.
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