FDA Fast Tracks SGR-1505 for Relapsed Waldenström Macroglobulinemia

SGR-1505, an oral investigational MALT1 inhibitor, has received FDA Fast Track Designation for the treatment of adult patients with relapsed or refractory Waldenström Macroglobulinemia (WM) after at least two lines of therapy, including a Bruton’s tyrosine kinase inhibitor.¹

SGR-1505 has shown promising efficacy and safety in an ongoing, phase 1 dose-escalation study. Safety and tolerability data of 33 patients with relapsed or refractory B-cell malignancies, including four patients with WM, were presented at the European Hematology Association 2025 Congress.²

All three patients with WM who had at least one year of follow-up achieved objective responses across five dose levels, including one with a partial response and two with a minor response as per the 6th International Workshop on WM guidelines. Investigators observed no dose-limiting toxicities, treatment-related serious adverse events, or deaths related to adverse events.²

“Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients,” said Karen Akinsanya, PhD, president, head of therapeutics R&D, and chief strategy officer, partnerships at Schrödinger, in a press release.¹ “This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens.”