FDA approves Jakafi for chronic GVHD
The FDA approved ruxolitinib for treatment of certain patients with chronic graft-versus-host disease.
The approval applies to use of the agent by patients aged 12 years or older who failed one or two lines of systemic therapy.
Ruxolitinib (Jakafi, Incyte), an oral Janus kinase 1/2 inhibitor, previously received approval for treatment of patients aged 12 years or older with steroid-refractory acute GVHD.
The FDA based the new indication on results of the randomized phase 3 REACH3 study, which compared ruxolitinib with best available therapy for treatment of steroid-refractory chronic GVHD after allogeneic stem cell transplantation.
Overall response rate at week 24 served as the primary endpoint.
As Healio previously reported, results showed a significant improvement in ORR at week 24 among ruxolitinib-treated patients (49.7% vs. 25.6%; P < .0001).
“Nearly half of the people who develop chronic GVHD do not respond adequately to steroids — the current standard of care — making this life-threatening condition particularly challenging to treat,” principal investigator Robert Zeiser, MD, of the department of hematology, oncology and stem cell transplantation at University Medical Center Freiburg in Germany, said in an Incyte-issued press release. “This approval represents a significant advancement in the treatment of appropriate patients with chronic GVHD, for both the patients who face a poor prognosis and the health care providers who struggle to effectively treat them.”