FDA approves Monjuvi as part of combination regimen for relapsed or refractory DLBCL
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The FDA granted accelerated approval to tafasitamab-cxix in combination with lenalidomide for treatment of certain adults with pretreated diffuse large B-cell lymphoma.
The approval applies to use of the regimen by patients with relapsed or refractory disease not otherwise specified — including DLBCL arising from low-grade lymphoma — who are not eligible for autologous stem cell transplant, according to a press release issued by the developers of tafasitamab-cxix (Monjuvi; MorphoSys, Incyte).
This is the first FDA approval of a second-line treatment for adults with DLBCL who progressed during or after first-line therapy, according to the release.
Approximately one-third of patients with DLBCL — the most common type of non-Hodgkin lymphoma — do not respond to or relapse after first-line therapy, and about 10,000 people in the United States are diagnosed with autologous stem cell transplant-ineligible relapsed or refractory DLBCL each year.
Tafasitamab-cxix is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody.
The FDA based the approval on results of the phase 2 L-MIND study, an open-label, multicenter, single-arm study that evaluated tafasitamab-cxix plus lenalidomide (Revlimid, Celgene) for adults with relapsed or refractory DLBCL. All patients received one to three prior lines of therapy, including an anti-CD20-targeting therapy, and were not eligible for high-dose chemotherapy or refused subsequent autologous stem cell transplant.
Overall response rate served as the primary endpoint. Researchers reported a 55% ORR; 37% of patients achieved complete response and 18% achieved partial response. Median duration of response — a key secondary endpoint — was 21.7 months.
The most common adverse reactions reported in the study included neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection and decreased appetite. Nearly three-quarters (73%) of patients developed infections. Other adverse events included neutropenia (50%), thrombocytopenia (18%), anemia (7%) and infusion-related reactions (6%), and 3.7% of patients discontinued treatment due to neutropenia.
“The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States,” Gilles Salles, MD, professor and chair of the clinical hematology department at University of Lyon in France, and lead investigator of the L-MIND study, said in the release. “[This] FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy.”
The FDA previously granted fast track, breakthrough therapy and priority review designations to the combination.
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