INCY · 10-Q · 2026Q3 · Full report
Tafasitamab Indication Expansion
INCYTE CORP · 2026-10-29 · Importance 12 · Surprise 6 · In source text
MONJUVI was approved in the United States in June 2025 for adults with relapsed or refractory follicular lymphoma, in combination with rituximab and lenalidomide. MINJUVI received European Commission approval in December 2025 for relapsed or refractory follicular lymphoma (Grade 1–3a) after at least one systemic therapy line, and Japan approved the combination for adults with relapsed or refractory follicular lymphoma. In June 2026, Japan also approved MINJUVI with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma.
Key facts
- Global regulatory submissions for tafasitamab and lenalidomide with R-CHOP as first-line treatment for adults with newly diagnosed DLBCL were submitted and accepted in the second quarter of 2026; potential U.S. approval and launch are anticipated in the first quarter of 2027. source
- In June 2026, Japan approved MINJUVI in combination with lenalidomide for adults with relapsed or refractory DLBCL. source
- In January 2026, Incyte announced positive topline results from the Phase 3 frontMIND trial of tafasitamab and lenalidomide with R-CHOP as first-line therapy for DLBCL; the trial met its primary progression-free-survival endpoint and key secondary event-free-survival endpoint by investigator assessment, with no new safety signals. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Global regulatory submissions for tafasitamab and lenalidomide with R-CHOP as first-line treatment for adults with newly diagnosed DLBCL… |