Waldenstrom macroglobulinemia is a rare indolent B-cell lymphoplasmacytic lymphoma with monoclonal IgM overproduction and marrow involvement. It can lead to hyperviscosity, neuropathy, cytopenias, and organ-related complications.
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07548450 |
Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07464210 |
Nemtabrutinib, Bortezomib, and Rituximab for WM |
NOT_YET_RECRUITING | PHASE2 |
| NCT07387471 |
Study to Assess Change in Disease Activity of Oral Venetoclax in Adult Participants With Recurring Relapsed or Refractory (R/R) Waldenström Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) |
RECRUITING | PHASE2 |
| NCT07231952 |
A Study of Pirtobrutinib, Venetoclax, and Rituximab in People With Waldenström's Macroglobulinemia (WM)/Lymphoplasmacytic Lymphoma (LPL) |
RECRUITING | PHASE2 |
| NCT07101328 |
A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 ) |
NOT_YET_RECRUITING | PHASE1 |
| NCT06860880 |
Combating Cancer-Related Fatigue: A Personalized Supportive Care Program |
RECRUITING | NA |
| NCT06561347 |
Zanubrutinib, Bendamustine, Rituximab Prev. Untreated WM |
RECRUITING | PHASE2 |
| NCT06547866 |
Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia |
NOT_YET_RECRUITING | PHASE2 |
| NCT06544265 |
SynKIR-310 for Relapsed/Refractory B-NHL |
RECRUITING | PHASE1 |
| NCT06510491 |
Epcoritamab in Previously Treated WM |
RECRUITING | PHASE2 |
