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SGR-1505 granted FDA fast track designation for the treatment of patients with R/R Waldenström macroglobulinemia
On June 27, 2025, the U.S. Food and Drug Administration (FDA) granted fast track designation to SGR-1505, an oral, investigational MALT1 inhibitor, for the treatment of adult patients with Waldenström macroglobulinemia after ≥2 prior lines of therapy, including a Bruton’s tyrosine kinase inhibitor (BTKi).1
The efficacy and safety of SGR-1505 in patients with relapsed/refractory (R/R) B-cell malignancies is currently being assessed in a phase I trial (NCT05544019).1 Initial data presented at the European Hematology Association (EHA) 2025 Hybrid Congress showed signs of preliminary efficacy and a favorable safety profile in patients with B-cell malignancies, including patients with Waldenström macroglobulinemia who were previously treated with a BTKi.1
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