Graft-vs-Host Disease

An off-the-shelf BCMA-directed CAR T-cell therapy generated a 100% overall response rate and universal MRD negativity in heavily pretreated myeloma.

Maintenance with chidamide and azacitidine generated high 3-year overall survival and a low relapse incidence in high-risk AML after allogeneic transplant.

The FDA and Atara Biotherapeutics completed a Type A meeting to discuss the CRL for tabelecleucel in post-transplant lymphoproliferative disease.

Orca-Q Receives FDA RMAT Designation for High-Risk Hematologic Malignancies.

The FDA has approved a once-daily, extended-release formulation of ruxolitinib for select myelofibrosis, polycythemia vera, and graft-vs-host disease.

Bortezomib maintenance was associated with lower rates of moderate-to-severe cGVHD in newly diagnosed multiple myeloma after allo-HSCT.

The FDA grants full approval to brexu-cel in mantle cell lymphoma, grants priority review to a lirafugratinib NDA in FGFR2+ pretreated cholangiocarcinoma, and more.

Use of ruxolitinib before, during, and after allogeneic stem cell transplant was associated with low rates of GVHD in myelofibrosis.

The FDA has extended the PDUFA date for the Orca-T BLA to July 6, 2026.

Venetoclax plus decitabine/cedazuridine after a venetoclax-based RIC regimen was effective and safe in myelodysplastic syndromes or acute myeloid leukemia.

Allo-HSCT did not improve survival outcomes in patients with lower-risk myelodysplastic syndrome who had some higher-risk features.

Alfonso Molina, MD, MPH, discusses a phase 1 trial evaluating Orca-T with allogeneic CAR T-cell therapy in high-risk B-cell acute lymphoblastic leukemia.

Age was correlated with worse survival among those undergoing allogenic hematopoietic cell transplantation for acute lymphoblastic leukemia.

Adoptive cell therapy elicited MRD-negative responses with low rates of GVHD and neurotoxicities in adult patients with high-risk B-ALL.

Orca-T/reduced-intensity conditioning was effective and decreased GVHD incidence vs PTCy/reduced-intensity conditioning in hematologic malignancies.

Ustekinumab plus prophylaxis did not reduce acute GVHD in patients who underwent HCT from matched unrelated donors.

Long-term follow-up data from the AGAVE-201 trial showed that safety and survival outcomes with axatilimab were maintained in patients with chronic GVHD.

Researchers at Roswell Park Comprehensive Care Center discover method of reducing acute graft-versus-host disease risk in blood cancers.

The microbiota-based therapy had a favorable safety profile and demonstrated response-driven prolongation of survival in this patient population.

A panel of hematologic cancer experts discusses data on GVHD management from the 2025 SOHO Annual Meeting.

Panelists discuss how recent FDA approvals of 4 agents (ibrutinib, ruxolitinib, belumosudil, and axatilimab-csfr) have expanded treatment options for chronic graft-vs-host disease, with each drug targeting different mechanisms including BTK inhibition, JAK1/JAK2 inhibition, and ROCK2 pathway modulation, while also noting significant advances in disease prevention strategies.

Pegtarazimod has received orphan drug designation from the European Medicines Agency for the management of graft-vs-host disease.