FDA Approves Tafasitamab for Follicular Lymphoma

Good news for adults battling a specific type of blood cancer: on June 18, 2025, the FDA gave its stamp of approval to tafasitamab-cxix, known commercially as Monjuvi (Incyte/MorphoSys), to be used in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).¹ This approval offers a promising new treatment option for patients whose disease has returned or hasn't responded to previous therapies.

FL represents roughly 20% to 30% of all non-Hodgkin lymphoma diagnoses, with approximately 14,000 new cases diagnosed in the US annually. | Image credit: wladimir1804 - stock.adobe.com

Prior to this, tafasitamab was only indicated to treat adults with relapsed or refractory diffuse large B-cell lymphoma.²

Follicular lymphoma is the second most common type of non-Hodgkin lymphoma, and although it's often slow-growing, it can be challenging to treat, especially when it recurs.³ FL represents roughly 20% to 30% of all non-Hodgkin lymphoma diagnoses, with approximately 14,000 new cases diagnosed each year in the US.

"Patients living with relapsed or refractory FL have been waiting for new options that improve progression-free survival without substantial increase in side effects. Based on the data from the inMIND trial of Monjuvi, today’s approval brings to this patient population the first CD19- and CD20-targeted immunotherapy combination and a potential new treatment standard,” said Hervé Hoppenot, CEO of Incyte, in a statement celebrating the approval.⁴ “This second US approval for Monjuvi reinforces our commitment to advancing innovation for the lymphoma community.”

The FDA's decision was based on results from the inMIND clinical trial (NCT04680052),⁵ a double-blind, placebo-controlled study, that involved 548 patients with relapsed or refractory FL. These patients had already undergone at least 1 prior line of treatment, with some having received multiple therapies.

The key takeaway from the inMIND trial was a significant improvement in progression-free survival (PFS) for patients who received the tafasitamab combination. PFS essentially measures how long patients live without their disease getting worse. After a median follow-up of just over a year (14.1 months), the estimated median PFS in the tafasitamab arm was a remarkable 22.4 months compared with 13.9 months in the control group. This statistically significant difference highlights the potential of this new treatment to extend the period of disease control for patients.

Like any powerful medication, tafasitamab comes with potential adverse effects.¹ The trial data indicated that serious adverse reactions occurred in 33% of patients receiving tafasitamab-cxix, with serious infections being reported in 24%. It's important for patients and their health care providers to be aware of these potential risks, which include infusion-related reactions, myelosuppression (a decrease in bone marrow activity, leading to lower blood cell counts), and various infections.

The recommended dosage for tafasitamab-cxix is 12 mg/kg, administered intravenously for a maximum of 12 cycles, alongside lenalidomide and rituximab. It's crucial to note that this approval is specifically for FL, and tafasitamab is not currently indicated or recommended for relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

This approval also showcased the power of international collaboration in bringing new treatments to patients faster. The review of tafasitamab was conducted under Project Orbis, an initiative of the FDA's Oncology Center of Excellence. Project Orbis facilitates the concurrent submission and review of oncology drugs among international partners. For this particular approval, the FDA worked closely with the Australian Therapeutic Goods Administration and Health Canada, demonstrating a shared commitment to accelerating access to innovative cancer therapies globally. The application was also granted priority review and received orphan drug designation for FL, both programs designed to expedite the development and review of treatments for serious conditions and rare diseases.

“While the initial responses to FL 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,” said Mitchell Smith, MD, PhD, chief medical officer at the Follicular Lymphoma Foundation.³ "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.”

References

1. FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. Press release. FDA. June 18, 2025. Accessed June 20, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
2. FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma. FDA. Updated August 3, 2020. Accessed June 20, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tafasitamab-cxix-diffuse-large-b-cell-lymphoma
3. Follicular lymphoma (FL). Leukemia & Lymphoma Society. Accessed June 20, 2025. https://www.lls.org/research/follicular-lymphoma-fl
4. Incyte announces FDA approval of Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma. Press release. Incyte. June 18, 2025. Acessed June 20, 2025. https://www.businesswire.com/news/home/20250615896694/en/Incyte-Announces-FDA-Approval-of-Monjuvi-tafasitamab-cxix-in-Combination-with-Rituximab-and-Lenalidomide-for-Patients-with-Relapsed-or-Refractory-Follicular-Lymphoma
5. Sehn LH, Luminari S, Scholz CW, et al. Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND). Blood. 2024;144(2):LBA-1. doi:10.1182/blood-2024-212970