FDA Grants Accelerated Approval to Tafasitamab-cxix for Relapsed/Refractory DLBCL

The FDA has granted accelerated approval to tafasitamab-cxix in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for autologous hematopoietic cell transplantation (AHCT). Tafasitamab-cxix is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody and is the first approved second-line treatment for this patient population.

Approval was supported by data from the phase II L-MIND study, an open label, multicenter trial of tafasitamab-cxix in combination with lenalidomide in adults with relapsed/refractory DLBCL who have received 1-3 prior lines of therapy (including an anti-CD20 targeting therapy) and are ineligible for high-dose chemotherapy or AHCT.

The overall response rate, the study’s primary endpoint, was 55%, including a complete response rate of 37% and a partial response rate of 18%. The median duration of response was 21.7 months.

The most common adverse events (occurring in >20% of patients) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

Tafasitamab-cxix was granted the FDA’s Fast Track, Breakthrough Therapy, and Priority Review designations.

Sources: FDA news release, July 31, 2020; MorphoSys press release, August 1, 2020.