FDA Approves Monjuvi With Revlimid and Rituxan for Follicular Lymphoma

The FDA approved Monjuvi with Revlimid and Rituxan for R/R follicular lymphoma: © stock.adobe.com.

The U.S. Food and Drug Administration (FDA) approved treatment with Monjuvi (tafasitamab-cxix) plus Revlimid (lenalidomide) and Rituxan (rituximab) for adults with relapsed or refractory follicular lymphoma.

The effectiveness of Monjuvi was studied in the double-blind, placebo-controlled inMIND trial which enrolled 548 patients with relapsed or refractory disease. Eligbile participants were randomly assigned to receive either Monjuvi or placebo alongside Revlimid and Rituxan. Most of the patients enrolled on the study had undergone one previous systemic treatment, while 25% had receoved two prior treatments and 20% had three or more.

The main measure of efficacy was investigator-assessed progression-free survival. After 14.1 months of follow-up, progression-free survival was statistically significantly longer with Monjuvi compared to placebo, with a median of 22.4 months versus 13.9 months respectively.

Serious side effects occurred in 33% of patients receiving Monjuvi, including serious infections in 24%. The Monjuvi prescribing information includes warnings for infusion-related reactions, low blood counts, and infections.

The recommended dose of Monjuvi is 12 milligrams per kilogram given by intravenous infusion for up to 12 cycles with lenalidomide and rituximab. Monjuvi is not approved or recommended for patients with relapsed or refractory marginal zone lymphoma outside of clinical trials.

This review was done through Project Orbis, a program from the FDA Oncology Center of Excellence that helps speed up the review of cancer drugs by working with regulatory agencies in other countries at the same time. For this review, the FDA partnered with Australia’s Therapeutic Goods Administration and Health Canada, which are still completing their own evaluations.

To help with the process, the FDA used an Assessment Aid — a voluntary document from the drug’s maker designed to make the review smoother.

This application was given priority review. Tafasitamab-cxix also received orphan drug status for follicular lymphoma. You can find more about FDA’s expedited programs in their Guidance for Industry on Serious Conditions.

Previous Efficacy Findings

Monjuvi plus Revlimid and Rituxan reduced the risk of disease progression or death by 57% compared with placebo plus Revlimid and Rituxan, according to a phase 3 trial presented at the 2024 ASH Annual Meeting.

At a median follow-up of 14.1 months, median investigator-assessed progression-free survival was 22.4 months with the triplet (273 patients) versus 13.9 months with Revlimid and Rituxan alone (275 patients).

By independent review committee assessment, median progression-free survival was not yet reached with the triplet versus 16 months with the doublet.

“The inMIND phase 3 study met its primary end point of prolonging PFS in relapsed/refractory follicular lymphoma,” Dr. Laurie H. Sehn said in a presentation of the data. “Benefit was observed in all prespecified subgroups, including patients with POD24 [progression of disease within 24 months of initial diagnosis], [those who were] refractory to prior anti-CD20 monoclonal antibodies, and [those] receiving multiple prior lines of therapy.”

Sehn is a lead study author and currently serves as a clinical professor of medicine, Faculty of Medicine, Division of Medical Oncology, at the University of British Columbia, in Vancouver, Canada.

Reference:

“FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma.” Press release. U.S. Food and Drug Administration. June 18, 2025.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.