Dr Gopal on the FDA Approval of Tafasitamab in R/R Follicular Lymphoma

“[Tafasitamab] offers another non-chemotherapy option for patients in the second line, where we didn’t really have this before. Most non-chemotherapy agents are approved in the third line or beyond, [this approval] offers an opportunity for a non-chemotherapy option that can improve progression-free survival in the second line.”

Ajay K. Gopal, MD, FACP, the medical director for Hematology, Malignancies/Hematology, the clinical research director for the Lymphoma Program and an professor in the Clinical Research Division at Fred Hutch Cancer Center; professor of Hematology and Oncology in the Division of Hematology and Oncology at the University of Washington School of Medicine, and the Stephen Hans Petersdorf, MD, Endowed Chair in Cancer Care at the University of Washington Medicine, discussed the significance of the FDA approval of tafasitamab-cxix (Monjuvi) plus lenalidomide (Revlimid) and rituximab (Rituxan) for the treatment of patients with relapsed/refractory follicular lymphoma.

In June 2025, the FDA approved tafasitamab in combination with lenalidomide and rituximab for the treatment of patients with relapsed/refractory follicular lymphoma. The approval was supported by data from the phase 3 inMIND trial (NCT04680052), which evaluated the combination of tafasitamab plus lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab. Patients were required to have previously received at least 1 line of systemic therapy with an anti-CD20 immunotherapy or chemo-immunotherapy.

The primary significance of the FDA approval of tafasitamab is that it offers a non-chemotherapy option for the treatment of patients with relapsed/refractory follicular lymphoma in the second-line setting, which had not been previously established in the landscape, Gopal began. He explained that non-chemotherapy agents had mostly been available in the third line or beyond.

Furthermore, follicular lymphoma is considered a chronic disease, Gopal continued. With this consideration, he emphasized that it’s important to be aware of the safety profile of treatments, particularly those that may cause secondary or long-term adverse effects [AEs]. Therefore, the amount of chemotherapy given to patients is intentionally limited, he said. Now, tafasitamab addresses this unmet need, which may not lead to long-term AEs and improves progression-free survival outcomes.