The supplemental Biologics License Application is supported by data from the phase 2 ABA2 trial (ClinicalTrials.gov Identifier: NCT01743131) and real world evidence from a registry trial.
Researchers sought to determine whether GVHD prophylaxis with posttransplant cyclophosphamide following allo-HSCT would be associated with a higher risk of infection.
Researchers sought to determine whether panobinostat may help to prevent GVHD in patients who receive stem cell transplant with matched donors.
Researchers sought to determine if a single dose of posttransplant cyclophosphamide is as effective as a 2-dose regimen in patients undergoing hematopoietic cell transplantation with matched-unrelated donors.
Researchers sought to determine whether posttransplant cyclophosphamide would be effective in GVHD prophylaxis for patients who underwent mismatched unrelated donor HCT.
The approval was based on data from a phase 2 trial that evaluated Rezurock in 65 patients with chronic GVHD who received 2 to 5 prior lines of systemic therapy.
Researchers sough to determine whether belumosudil would help treat patients with chronic GVHD.
Researchers sought to determine if GVHD prophylaxis with ATLG would be the same as PTCy in terms of long-term outcomes.
Researchers sought to determine whether targeting BAFF and BCR pathways may improve outcomes in patients with chronic GVHD risk.
Researchers sought to determine whether adding ATG would help improve prophylaxis for GVHD in patients with lymphoid malignancies.
