FDA Expands Approval of Imbruvica to Include Pediatric Patients

The FDA has expanded its approval of Pharmacyclics and Janssen’s Imbruvica (ibrutinib) for the treatment of pediatric patients one year or older with chronic graft versus host disease (GVHD) after failure of one or more lines of systemic therapy.

GVHD is a potentially fatal condition that can occur after a stem cell or bone marrow transplant when donor cells attack the recipient's body.

The new approval was based on results from a phase 1/2 study in which treated patients had an overall response rate of 60 percent by week 25.

The FDA has also approved an oral suspension formulation of the drug, which is now available in capsules, tablets and the suspension formulation.