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FDA Approvals, News & UpdatesNewsworthy

Ibrutinib First Treatment Approved by the FDA for Chronic Graft-versus-Host Disease

December 2017 Vol 3 No 6

On August 2, 2017, the FDA approved a new indication for Imbruvica (ibrutinib; from Pharmacyclics) for adults with chronic graft-versus-host disease after 1 or more systemic therapies. Imbruvica is the first drug approved specifically for patients with this type of cancer. Imbruvica was previously approved by the FDA for different types of leukemia and lymphoma.

The approval was based on a clinical trial in which 88% of patients had 2 or more organs involved at the start of the study. The use of Imbruvica led to improvement in all the involved organs, and in many patients this improvement lasted 5 months or longer.

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Last modified: January 2, 2018

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