The Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Pharmacyclics) for the treatment of adults with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This marks the first FDA-approved treatment for cGVHD.

Findings from the multicenter, open-label, single-arm PCYC-1129-CA Study, which included patients with cGVHD who failed first-line corticosteroid therapy and required additional therapy (n=42), supported the FDA approval. Most patients (88%) had at least two organs involved at treatment start with the mouth, skin, and gastrointestinal tract being the most common organs involved. 

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After receiving Imbruvica 420mg once daily, the overall response rate was reported to be 67% (95% CI: 51, 80). The median time to best response coinciding with the first scheduled response assessment was 12.3 weeks. Patient response was seen for all organs involved with cGVHD, including the skin, mouth, liver, and gastrointestinal tract. Nearly half of the patients (48%) had responses lasting ≥5 months. 

Adverse reactions observed in ≥20% of patients were fatigue, bruising, diarrhea, thrombocytopenia, stomatitis, muscle spasms, nausea, hemorrhage, anemia, and pneumonia; atrial fibrillation was seen in one patient. Discontinuation due to adverse reactions was seen in 24% of patients. 

Imbruvica, a kinase inhibitor, is already approved to treat chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion, Waldenström’s macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma. It is available as 140mg capsules.

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