Incyte announced that the European Commission has granted marketing authorization for its antibody‑drug conjugate Minjuvi (tafasitamab) in the treatment of relapsed or refractory follicular lymphoma, marking the first approval of a CD19‑ and CD20‑dual‑targeted immunotherapy in Europe for this indication.
Follicular lymphoma is the most common slow‑growing form of B‑cell non‑Hodgkin lymphoma, representing roughly 30 % of NHL cases worldwide. In Europe the disease accounts for a sizable share of oncology sales, and the approval of Minjuvi provides patients with a chemotherapy‑free option that has shown a 57 % reduction in the risk of disease progression in the Phase 3 inMIND trial, with median progression‑free survival of 22.4 months versus 13.9 months in the control arm.
The authorization expands Minjuvi’s commercial reach beyond the United States, creating a new revenue stream in a market where Incyte’s existing products have limited presence. The company’s recent financials—total revenue of $1.37 billion in Q3 2025, a 20 % year‑over‑year increase, and a full‑year 2025 net product revenue guidance of $4.23 billion to $4.32 billion—illustrate the company’s growth trajectory. The European approval is expected to accelerate revenue growth and further diversify the company’s portfolio away from its flagship JAKAFI franchise.
Bill Meury, President and CEO of Incyte, said, “The EC approval of Minjuvi addresses a critical need, bringing a new, first‑of‑its‑kind, chemotherapy‑free option to patients in Europe with relapsed or refractory FL. Historically, FL patients have had limited treatment options in the second‑line setting, and we are proud to drive this important advancement for the lymphoma community as we seek to deliver innovative medicines for patients with cancer.”
Investors have responded positively to the approval, citing the drug’s strong clinical profile and the potential to capture a significant share of the European follicular lymphoma market. Analysts note that the approval complements Incyt’s broader strategy of expanding its oncology pipeline and reducing reliance on a single product line.
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