April 27th 2025
The FDA’s decision not to grant breakthrough designation or accelerated approval for itolizumab in acute GVHD has led to the discontinuation of the pivotal phase 3 EQUATOR trial.
FDA Approves Abatacept to Proactively Treat Acute Graft-Versus-Host-Disease
December 16th 2021Abatacept is now available for use in combination with certain immunosuppressants to prevent moderate to severe acute-graft-versus-host disease for select patients who have received unrelated donor hematopoietic stem cell transplant.
New Drug Approvals Expand cGVHD Treatment Beyond Steroids, But Real-World Data Still Needed
October 30th 2021Ruxolitinib and belumosudil represent FDA-approved treatment options to manage cGVHD, however, real world data will determine best practices for treatment and future research directions within the space.
FDA Grants ALPN-101 Orphan Drug Designations for GVHD Prevention, Treatment
March 19th 2020The FDA has granted 2 Orphan Drug Designations to ALPN-101 for the prevention and treatment of acute graft-versus-host-disease (GVHD), according to Alpine Immune Sciences, Inc., the company developing the first-in-class selective dual T cell costimulation inhibitor.
Itacitinib Misses GVHD Treatment Goal
January 7th 2020The combination of itacitinib and corticosteroids did not induce a statistically significant improvement in overall response rate (ORR) at day 28 compared with placebo plus corticosteroids in patients with treatment-naïve acute graft-versus-host disease (aGVHD).
FDA Grants Breakthrough Therapy Designation for GVHD Prevention Drug
December 4th 2019The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to abatacept (Orencia) to prevent moderate or severe acute graft-versus-host disease (GvHD) in patients who underwent a hematopoietic stem cell transplant and are not related to their donors, according to Bristol-Myers Squibb, the manufacturer of the drug.
FDA Grants Priority Review to Ruxolitinib for Acute GVHD
October 27th 2018The Food and Drug Administration has granted a priority review to the supplemental new drug application for ruxolitinib (Jakafi) to treat patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids.