Ibrutinib now FDA-approved for treatment of chronic Graft versus Host Disease  after a hematopoietic stem cell transplant

A drug previously approved for adults with certain types of lymphoma or leukemia has become the first FDA approved medication for chronic graft-vs-host disease (GVHD).

Ibrutinib, marketed as Imbruvica, inhibits Bruton tyrosine kinase, a protein that plays a role in the survival and spread of malignant B cells. The medication is indicated for adults who develop chronic GVHD after a hematopoietic stem cell transplant but don’t respond to systemic therapy. An estimated 30% to 70% of patients who undergo these transplants subsequently develop chronic GVHD.

The drug’s approval is based on an ongoing, single-arm Phase I and Phase 2 trial that evaluated ibrutinib’s safety and efficacy in 42 patients with chronic GVHD who didn’t respond to first-line corticosteroid therapy.

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