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FDA Approves Imbruvica for Chronic GVHD
FDA news release; 2017 Aug 2
The FDA has approved Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (GVHD) after failure of 1 or more treatments. This is the first FDA-approved therapy for such treatment.
Indications: Imbruvica is a kinase inhibitor indicated for the treatment of adult patients with chronic GVHD after failure of 1 or more lines of systemic therapy.
Dosage and administration: 420 mg taken orally once daily.
Efficacy and safety: Approval is based on a single-arm trial of 42 patients with chronic GVHD whose symptoms persisted despite standard treatment with corticosteroids. ~Two-thirds of patients experienced improvements in their symptoms. In nearly half, improvement lasted for up to 5 months or longer.
Side effects/risks: The most common adverse reactions are fatigue, bruising, diarrhea, thrombocytopenia, muscle spasms, stomatitis, nausea, hemorrhage, anemia, and pneumonia.
FDA approves treatment for chronic graft versus host disease. [news release]. Silver Spring, MD: FDA. August 2, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569710.htm. Accessed August 7, 2017.
Imbruvica [package insert]. Sunnyvale, CA: Pharmacyclics LLC. 2017. https://www.imbruvica.com/docs/librariesprovider7/default-document-library/prescribing_information.pdf. Accessed August 7, 2017.