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Pharmaceuticals / Submissions and Approvals

FDA Grants Imbruvica First Indication in Chronic Graft-Versus-Host Disease

Aug. 7, 2017

The FDA expanded its approval of Pharmacyclics’ Imbruvica (ibrutinib) to include the treatment chronic graft versus host disease after failure of one or more treatments — making it the first FDA-approved therapy for the treatment of cGVHD, which is estimated to occur in 30-70 percent of all patients that receive hematopoietic stem cell transplants.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said the approval highlights how a known cancer treatment can find new use in treating a condition that may occur in patients with blood cancer. The FDA granted the application priority review, orphan drug and breakthrough therapy designations.

Imbruvica was studied in a single-arm trial of 42 patients with cGVHD whose symptoms persisted despite standard treatment with corticosteroids, with two-thirds of patients showing improvements in symptoms. In 48 percent of patients, improvements lasted five months or longer.

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