FDA Approves Ruxolitinib for the Treatment of Previously Treated Chronic Graft-Versus-Host Disease

Article

Patients with chronic graft-versus-host disease who have received prior therapy can now receive treatment with ruxolitinib following its approval by the FDA.

Ruxolitinib (Jakafi) has received approval from the FDA for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) following failure of 1 to 2 lines of systemic therapy, according to a press release from drug developer Incyte.

The approval was based on findings from the open-label, multicenter phase 3 REACH3 study (NCT03112603), which compared the use of ruxolitinib to best available therapy in those with steroid-refractory GVHD following allogenic stem cell transplant. Notably, the primary end point of overall response rate (ORR) at 24-weeks was 49.7% in the ruxolitinib arm vs 25.6% in the best available therapy arm (P <.0001). Additionally, the ORR on cycle 7, day 1 was 70% for the experimental cohort and 57% for the control group.

“GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies,” Steven Stein, MD, chief medical officer at Incyte, said in a press release. “Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today’s approval of Jakafi for certain people who develop chronic GVHD.”

Reference

Incyte announces FDA approval of Jakafi® (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD). News release. Incyte. September 22, 2021. Accessed September 22, 2021. https://bit.ly/3lPathJ

Recent Videos
Educating community practices on CAR T referral and sequencing treatment strategies may help increase CAR T utilization.
A retrospective study sought to assess CRS and ICANS onset and duration, as well as non-relapse mortality causes in patients infused with CAR T-cell therapies.
A retrospective study sought to assess CRS and ICANS onset and duration, as well as non-relapse mortality causes in patients infused with CAR T-cell therapies.
A retrospective study sought to assess CRS and ICANS onset and duration, as well as non-relapse mortality causes in patients infused with CAR T-cell therapies.
Future meetings may address how immunotherapy, bispecific agents, and CAR T-cell therapies can further impact the AML treatment paradigm.
Treatment with revumenib appeared to demonstrate efficacy among patients with KMT2A-rearranged acute leukemia in the phase 2 AUGMENT-101 study.
Advocacy groups such as Cancer Support Community and the Leukemia & Lymphoma Society may help support patients with CML undergoing treatment.
Data from the REVEAL study affirm elevated white blood cell counts and higher variant allele frequency as risk factors for progression in polycythemia vera.
Additional analyses of patient-reported outcomes and MRD status in the QuANTUM-First trial are also ongoing, says Harry P. Erba, MD, PhD.
Investigators must continue to explore the space for lisocabtagene maraleucel in mantle cell lymphoma, according to Manali Kamdar, MD.
Related Content
Improving Disease Modification and Immune Responses in Myelofibrosis With Pelabresib

Improving Disease Modification and Immune Responses in Myelofibrosis With Pelabresib

ONCOLOGY Staff
November 16th 2024
Article

David M. Swoboda, MD, and Andrew Kuykendall, MD, spoke about the current treatment strategies and potential advancements that may improve outcomes such as spleen volume reduction in the myelofibrosis field.

A panel of expert pharmacists provides their perspectives on gene therapy agents such as exagamglogene autotemcel in the management of sickle cell disease.

Leveraging Ex Vivo Gene Therapy Advancements in Hemoglobinopathies and Metabolic Diseases

Alexis K. Kuhn, PharmD, BCOP ;Katie Bruce, PharmD, BCPPS;Susie Long, PharmD
October 21st 2024
Podcast

A panel of expert pharmacists provides their perspectives on gene therapy agents such as exagamglogene autotemcel in the management of sickle cell disease.

Vascular biomarkers reveal a unique toxicity profile of posttransplant cyclophosphamide: secondary analysis of BMT CTN 0402 and 1202

Vascular biomarkers reveal a unique toxicity profile of posttransplant cyclophosphamide: secondary analysis of BMT CTN 0402 and 1202

American Society for Transplantation and Cellular Therapy
October 30th 2024
Article

Posttransplant cyclophosphamide leads to unique changes in vascular biomarkers, revealing a distinct toxicity profile compared to other GVHD prophylaxis regimens.

Experts in multiple myeloma weigh the benefits and risks of administering CAR T-cell therapy to patients based on prior reports of secondary malignancies.

Managing Secondary Cancer Risks After CAR T-Cell Therapy in Multiple Myeloma Subgroups

Rahul Banerjee, MD, FACP;Noopur Raje, MD
September 2nd 2024
Podcast

Experts in multiple myeloma weigh the benefits and risks of administering CAR T-cell therapy to patients based on prior reports of secondary malignancies.

Data from the IMerge trial affirm the enduring responses and clinical benefit with imetelstat in those with transfusion-dependent MDS.

Lower-Risk MDS Population Has Enduring RBC-TI Following Imetelstat Therapy

Ashling Wahner
September 8th 2024
Article

Data from the IMerge trial affirm the enduring responses and clinical benefit with imetelstat in those with transfusion-dependent MDS.

Data from the PERSEUS trial support the benefit of D-VRd and DR maintenance as a standard of care in transplant-eligible newly diagnosed multiple myeloma.

Subcutaneous Daratumumab Combo Improves MRD-Negative Status in NDMM

Chris Ryan
September 7th 2024
Article

Data from the PERSEUS trial support the benefit of D-VRd and DR maintenance as a standard of care in transplant-eligible newly diagnosed multiple myeloma.