Imbruvica is FDA approved to treat children with chronic graft versus host disease
AbbVie announced that the FDA approved the use of Imbruvica (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy
The approval is AbbVie's first pediatric indication for Imbruvica, marking the 12th FDA approval for Imbruvica and the first Bruton's tyrosine kinase inhibitor (BTKi) treatment approved for a pediatric patient population. This approval also marks the first approved treatment option for children under 12 years of age suffering from cGVHD.
The approval is primarily based on positive results from the iMAGINE Phase 1/II clinical trial.
The iMAGINE study demonstrated an Overall Response Rate (ORR) through week 25 of 60% (Confidence Interval [CI] 95%; 44-74) in patients median age 13 years (range, 1-19 years) (n=47) with relapsed/refractory (R/R) moderate to severe cGVHD. The median duration of response was 5.3 months (95% CI: 2.8, 8.8). Safety was consistent with the established profile for Imbruvica, with observed adverse reactions (ARs) consistent with those observed in adult patients with moderate to severe cGVHD. The most common ARs (occurring in 20% or more of patients), including laboratory abnormalities, were anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia, and headache.
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