FDA Authorizes Tafasitamab-cxix for Relapsed/Refractory Follicular Lymphoma

On June 18, 2025, the Food and Drug Administration (FDA) granted approval for the use of tafasitamab-cxix, marketed as Monjuvi by Incyte Corporation, in combination with lenalidomide and rituximab. This approval is specifically for adult patients suffering from relapsed or refractory follicular lymphoma (FL), a type of non-Hodgkin lymphoma. This decision marks a significant advancement in treatment options for individuals battling this condition.

The approval was based on results from the inMIND clinical trial, a rigorous double-blind, placebo-controlled study. This trial involved 548 participants with relapsed or refractory follicular lymphoma. The participants were randomly assigned to receive either tafasitamab-cxix or a placebo, both in conjunction with lenalidomide and rituximab. A considerable number of patients in the study, around 45%, had previously undergone two or more systemic therapy regimens.

A pivotal metric for assessing the efficacy of tafasitamab-cxix was the progression-free survival (PFS) rate, as determined by investigators. After a median follow-up period of 14.1 months, patients receiving tafasitamab-cxix demonstrated a notably improved PFS compared to those in the control group. The hazard ratio was calculated at 0.43, with a 95% confidence interval ranging from 0.32 to 0.58, and the statistical significance was underscored by a p-value of less than 0.0001. Specifically, the median PFS for the tafasitamab-cxix group was estimated at 22.4 months, in contrast to 13.9 months for the control group.

However, the use of tafasitamab-cxix does come with risks of adverse effects. Serious adverse reactions were observed in 33% of patients treated with tafasitamab-cxix, with serious infections occurring in 24% of these cases. Consequently, the prescribing information includes important warnings and precautions regarding potential infusion-related reactions, myelosuppression, and infections.

The FDA has recommended a dosage of 12 mg/kg of tafasitamab-cxix to be administered via intravenous infusion. This treatment is advised for a maximum of 12 cycles when used in combination with lenalidomide and rituximab. Notably, tafasitamab-cxix is not advised for patients with relapsed or refractory marginal zone lymphoma unless they are part of controlled clinical trials.

This approval process was part of Project Orbis, an initiative by the FDA's Oncology Center of Excellence, which facilitates the concurrent submission and review of oncology drugs among international partners. For this particular review, the FDA worked collaboratively with the Australian Therapeutic Goods Administration and Health Canada. While the FDA has completed its review, the applications are still under review by these other regulatory bodies.

The review utilized the Assessment Aid, a voluntary submission tool designed to streamline the FDA’s evaluation process. The application was granted priority review status, and tafasitamab-cxix received orphan drug designation specifically for follicular lymphoma. These expedited programs are part of the FDA’s efforts to accelerate the availability of treatments for serious conditions.

Healthcare professionals are encouraged to report any serious adverse events related to the use of tafasitamab-cxix or any other medication to the FDA’s MedWatch Reporting System. This ongoing feedback is crucial for monitoring the safety and efficacy of new treatments as they become part of standard medical practice.