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Imbruvica Now Also Indicated for Children with Chronic Graft-versus-Host Disease

Web Exclusives - FDA Approvals

On August 24, 2022, the FDA accelerated the approval of ibrutinib (Imbruvica; Pharmacyclics), a Bruton tyrosine kinase inhibitor, for chronic graft-versus-host disease (GVHD) in pediatric patients aged ≥1 year whose disease did not respond to ≥1 lines of systemic therapy. Concomitantly, the FDA approved a new oral suspension formulation of ibrutinib for use in this patient population.

Ibrutinib was previously approved for adults with chronic GVHD, marginal-zone lymphoma, Waldenström’s macroglobulinemia, chronic or small lymphocytic leukemia, and mantle-cell lymphoma.

The new indication was based on results of the open-label, multicenter, single-arm iMAGINE trial of 47 pediatric patients and young adults aged 1 year to <22 years with moderate or severe chronic GVHD who required additional treatment after ≥1 systemic therapies.

The main end point was overall response rate (ORR) through week 25. The ORR was 60% (95% confidence interval [CI], 44-74). The median duration of response was 5.3 months (95% CI, 2.8-8.8), and the median time from first response to new systemic therapies for chronic GVHD or death was 14.8 months (95% CI, 4.6-not evaluable).

“The new Imbruvica oral suspension formulation helps address challenges children may have with swallowing capsules or tablets,” said Paul A. Carpenter, MD, of Seattle Children’s Hospital, and a study investigator.

The most common (≥20%) adverse events were anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache.

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Last modified: November 17, 2022