FDA Approves Monjuvi for Relapsed, Refractory Follicular Lymphoma

MONDAY, June 23, 2024 (HealthDay News) — The U.S. Food and Drug Administration has approved Monjuvi (tafasitamab-cxix) for the treatment of adult patients with relapsed or refractory follicular lymphoma.

Monjuvi is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody to be used in combination with rituximab and lenalidomide to treat patients with relapsed or refractory follicular lymphoma.

The approval was based upon results from the phase 3 inMIND trial, which randomized patients in a double-blind manner to treatment with Monjuvi (273 patients) or placebo (275 patients) in combination with rituximab and lenalidomide. The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in the Monjuvi group: 27.5 percent of patients had an event in the treatment arm versus 47.6 percent in the control arm. For patients receiving Monjuvi in combination with rituximab and lenalidomide, median PFS by investigator assessment was 22.4 months, compared to 13.9 months in the control arm (hazard ratio, 0.43). With assessment by an independent review committee, median PFS was not reached by the Monjuvi group versus 16.0 months for the control arm (hazard ratio, 0.41).

Serious adverse reactions occurred in 33 percent of patients who received Monjuvi in combination with rituximab and lenalidomide, including serious infections in 24 percent of patients (pneumonia and COVID-19). Other serious adverse reactions included renal insufficiency (3.3 percent), second primary malignancies (2.9 percent), and febrile neutropenia (2.6 percent). Fatal adverse reactions (COVID-19, sepsis, and adenocarcinoma) occurred in 1.5 percent of patients.

“While the initial responses to follicular lymphoma treatment are often positive, recurrence can become increasingly difficult for patients to manage as they navigate emotions and the next treatment steps related to relapse,” Mitchell Smith, M.D., Ph.D., chief medical officer of the Follicular Lymphoma Foundation, said in a statement. “We are pleased that the FDA has approved tafasitamab, part of a treatment combination offering a new option for patients living with this chronic disease.”

Approval of Monjuvi was granted to Incyte.

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