The approval represents the first for a second-line treatment for adult patients who progressed during or after first-line therapy.
Officials with the FDA have approved tafasitamab-cxix (Monjuvi®, MorphoSys and Incyte) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). The approval represents the first by the FDA for a second-line treatment for adult patients who progressed during or after first-line therapy, according to MorphoSys and Incyte.
A humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, tafasitamab-cxix received accelerated approval based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Globally, DLBCL is the most common type of non-Hodgkin lymphoma in adults. The aggressive disease is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs, and about 1 in 3 patients do not respond to initial therapy or relapsing thereafter. In the United States, approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT, each year.
The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of tafasitamab-cxix in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. Results from the study showed an ORR of 55% (primary endpoint), including a complete response (CR) rate of 37%, and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months (key secondary endpoint).
Warnings and precautions for tafasitamab-cxix included infusion-related reactions (6%), serious or severe myelosuppression including neutropenia (50%), thrombocytopenia (18%), and anemia (7%); infections (73%), and embryo-fetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients. The most common adverse reactions (≥ 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.
The FDA previously granted Fast Track and Breakthrough Therapy Designation for the tafasitamab-cxix and lenalidomide combination in treatment of relapsed or refractory DLBCL. FDA.
Tafasitamab-cxix is expected to be commercially available in the United States shortly, according to MorphoSys and Incyte, which plan to co-commercialize this therapy in the US. Incyte has exclusive commercialization rights outside the US.
FDA Approves Monjuvi® (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) [news release]. Planegg & Munich, Germany, and Wilmington, DE; July 31, 2020: MorphoSys and Incyte. https://www.businesswire.com/news/home/20200731005497/en.