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BI‑1808 received a positive EMA COMP opinion for the orphan drug designation for cutaneous T-cell lymphoma
On November 17, 2025, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) announced a positive opinion for the orphan drug designation for BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of cutaneous T-cell lymphoma (CTCL).1
BI-1808 has demonstrated promising clinical activity in an ongoing phase I/IIa trial (NCT04752826), with updated results set to be presented at the upcoming 67th American Society of Hematology (ASH) Meeting and Exposition, December 6–9, 2025, Orlando, US.
BI-1808 has previously been granted fast track designation for the treatment of adult patients with relapsed/refractory (R/R) mycosis fungoides and Sézary syndrome, subtypes of CTCL, by the U.S. Food and Drug Administration (FDA).
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