News
Incyte eyes first-line nod for Tafasitamab in aggressive lymphoma
Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide
- By IPP Bureau
| January 07, 2026
Building on promising trial data, global pharma powerhouse Incyte plans to file a supplemental Biologics License Application (sBLA) for tafasitamab as a first-line therapy for adults with newly diagnosed DLBCL in the first half of 2026. "The frontMIND data will be submitted for presentation at an upcoming scientific meeting," the company said.
Tafasitamab, approved in combination with lenalidomide by the FDA in 2020 and the EMA in 2021, is currently indicated for adult patients with relapsed or refractory DLBCL, including cases arising from low-grade lymphoma, who are ineligible for autologous stem cell transplant.
Additionally, the FDA approved tafasitamab with lenalidomide and rituximab in June 2025 for adults with relapsed or refractory follicular lymphoma (FL). In November 2025, the EMA’s Committee for Medicinal Products for Human Use issued a positive opinion recommending tafasitamab for relapsed or refractory FL.
With DLBCL’s aggressive course and high relapse rate, Incyte’s move could mark a significant advance for patients in need of more effective frontline options.
