FDA approves ibrutinib for children with chronic GVHD

Based on the results of the Phase 1/2 iMAGINE trial, the FDA has approved ibrutinib for patients with chronic graft-versus-host disease in children

The FDA has approved ibrutinib (Imbruvica) as oral suspension or in capsule and tablet form for patients 1 year or older with chronic graft-versus-host disease (GVHD) and experience with 1 or more prior lines of failure Pediatric patients

Approval results are based on the Phase 1/2 iMAGINE trial (NCT03790332), which enrolled patients aged 1 to 22 years with moderate-to-severe GVHD (n = 47)

Overall, patients were excluded if they had single organ urogenital involvement as the only manifestation of chronic GVHD

The recommended dose of ibrutinib is 420 mg orally once daily for patients 12 years of age or older, and 240 mg/m2 once daily for patients younger than 12 years of age

Common adverse reactions include anemia, musculoskeletal pain, pyrexia, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache

Ibrutinib (ibrutinib) is a new targeted anti-cancer drug jointly developed by Johnson Johnson and Pharmacyclics.

On November 13, 2013, the U.

Ibrutinib was subsequently approved by the FDA for multiple indications, including mantle cell lymphoma, small lymphocytic lymphoma, chronic lymphocytic leukemia (CLL), graft-versus-host disease, Waldenström's macroglobulinemia, borderline area lymphoma

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FDA approves ibrutinib for pediatric patients with chronic graft versus host disease, including new oral suspension.