FDA Approvals of Systemic Therapy for Steroid-Refractory cGVHD
Panelists discuss how FDA-approved therapies such as ibrutinib, ruxolitinib, belumosudil, and axatilimab provide treatment options for steroid-refractory chronic graft-vs-host disease (cGVHD).
Second-Line Therapy and FDA Approvals
This segment reviews FDA-approved systemic therapies for chronic GVHD:
- Ibrutinib (2017): First approval for chronic GVHD after failure of ≥1 line of therapy
- Belumosudil (July 2021): Approved for chronic GVHD after ≥2 prior lines in patients ≥12 years
- Ruxolitinib (September 2021): Approved for chronic GVHD after 1-2 lines in patients ≥12 years
- Axatilimab (August 2024): Approved for chronic GVHD after ≥2 prior lines in adults and pediatric patients ≥40 kg
The panel discusses the long-term follow-up data from the ibrutinib trial, showing 69% overall response rate with higher efficacy in inflammatory features and moderate efficacy in sclerotic features. Common grade 3+ adverse events included pneumonia, fatigue, and diarrhea, with 43% discontinuation due to adverse effects.
Ruxolitinib Effective as Second-Line Therapy for Chronic GvHD
July 15th 2021In an interview with Targeted Oncology, Stephanie Lee, MD, MPH, reviewed the updated data from the REACH3 trial along with the efficacy of ruxolitinib in the greater chronic graft versus host disease population.
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Clinical Treatment Act Aims to Improve Survival, Close Racial Health Care Gap
June 28th 2021Across the United States, the health insurance coverage gap continues to impact millions of patients who are largely low-income or are racial minorities. After years of lobbying, Congress has passed the Clinical Treatment Act, which is legislation designed to improve access to health coverage.
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