
Graft-vs-Host Disease
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FDA Grants RMAT Designation to Orca-Q for High-Risk Hematologic Malignancies

FDA Clears Once-Daily Ruxolitinib Tablets for Myelofibrosis, Polycythemia Vera, and GVHD
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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.

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






































































