FDA Approves Monjuvi, Rituximab and Lenalidomide Combination for Relapsed or Refractory Follicular Lymphoma

The FDA has approved Incyte’s Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma (FL), according to a news release published yesterday. This approval provides a new chemotherapy-free treatment option for FL patients, a population with a disease that is typically indolent but chronic and prone to relapse.

Follicular lymphoma is the second most common form of non-Hodgkin lymphoma (NHL), accounting for up to 30% of cases. Despite its typically slow progression, it remains difficult to treat due to frequent recurrences and risk of transformation into more aggressive forms of lymphoma, such as large B-cell lymphoma. Approximately 20% of patients with relapsed or refractory follicular lymphoma develop disease progression within the first two years of chemotherapy and have a 5-year survival rate of 50%. Common symptoms of follicular lymphoma include swollen lymph nodes and fatigue. The median age of diagnosis is 65.

The recommended combination dose is 12 mg of Monjuvi, 20 mg of lenalidomide and 375 mg of rituximab, given intravenously, dependent on weight, according to the prescribing information.

The approval was based on results from the phase 3 inMIND trial, a global, double-blind, placebo-controlled study evaluating the combination therapy’s safety and efficacy. The study enrolled 654 adult patients with relapsed or refractory FL or marginal zone lymphoma. In the FL subgroup, Monjuvi demonstrated a significant improvement in progression-free survival (PFS) compared to the control group. Specifically, only 27.5% of patients receiving Monjuvi experienced disease progression, compared to 47.6% in the control group. The median PFS in the Monjuvi arm was 22.4 months, versus 13.9 months for the control. Results were consistent across multiple patient subgroups, and PFS measured by an Independent Review Committee aligned with investigator findings.

Serious adverse events were observed in 33% of patients receiving Monjuvi in combination with rituximab and lenalidomide, most notably serious infections in 24% of patients, including COVID-19 and pneumonia. Additional adverse reactions included renal insufficiency (3.3%), second primary malignancies (2.9%) and febrile neutropenia (2.6%). Fatal adverse events occurred in 1.5% of patients, with causes including sepsis and COVID-19. The most common side effects, occurring in at least 20% of patients, were respiratory tract infections, diarrhea, rash, fatigue and cough.

This marks the second U.S. approval for Monjuvi, following its accelerated FDA approval in 2020 for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults ineligible for stem cell transplant, in combination with lenalidomide.

Medical experts highlighted the significance of this approval.

“The FDA approval of Monjuvi in combination with rituximab and lenalidomide marks a significant advancement, offering a chemotherapy-free option that has demonstrated a meaningful reduction in the risk of disease progression across a broad patient population, including those with high-risk disease,” Christina Poh, M.D., assistant professor of Medicine at the University of Washington and Fred Hutchinson Cancer Center, said in the news release.

"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,” Mitchell Smith, M.D., Ph.D., CMO, Follicular Lymphoma Foundation, said in the news release.