Ibrutinib (Imbruvica) added another notch on its indications belt with its Aug. 2 approval by the U.S. Food and Drug Administration for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

The new indication makes ibrutinib the first FDA-approved therapy for the treatment of cGVHD, according to an FDA press release.

The approval was based on an open-label, multicenter, single-arm clinical trial that found a 67% response rate in 42 patients with cGVHD who did not respond to first-line corticosteroid therapy. The median time to response was 12.3 weeks, and responses persisted for at least 5 months in half of the patients. Treatment was discontinued because of adverse events in 24% of patients; 26% of the patients needed dose reductions. All of the specifics of that trial were covered in an article by our reporter at the annual congress of the European Hematology Association in Madrid. ( Ibrutinib dons new anti-GVHD hat .)

Ibrutinib’s other approved indications include 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, according to a press release from the FDA.

The recommended dose of ibrutinib for cGVHD is 420 mg (three 140 mg capsules once daily). Prescribing information is available on the FDA website .

Imbruvica is manufactured by Pharmacyclics.


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