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BI-1808 granted FDA fast track designation for the treatment of patients with cutaneous T-cell lymphoma
On April 29, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation to BI-1808, a first-in-class anti-TNFR2 antibody, for the treatment of adult patients with relapsed/refractory (R/R) mycosis fungoides and Sézary syndrome, subtypes of cutaneous T-cell lymphoma (CTCL).1
Phase I/IIa trial
An ongoing phase I/IIa trial (NCT04752826) is assessing the safety, tolerability, and efficacy of BI-1808 as a single agent, and in combination with pembrolizumab, in patients with advanced solid tumors and T-cell lymphoma.1 Results from the single-agent CTCL cohort showed three patients with a partial response and one patient with stable disease out of four evaluable patients.1
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