AbbVie's Imbruvica Scores First Approval For Pediatric Patients After Bone Marrow Transplant

The FDA approved AbbVie Inc's ABBV Imbruvica (ibrutinib) for pediatric patients one year and older with chronic graft versus host disease (cGVHD) after the 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 1/2 clinical trial.
cGVHD occurs when donated peripheral blood or bone marrow stem cells view the recipient's body as foreign, and the donated cells launch an immune attack on the body. Steroids are the current standard treatment for pediatric cGVHD.
The iMAGINE study demonstrated an Overall Response Rate (ORR) through week 25 of 60%. The median duration of response was 5.3 months.
The recommended dose of IMBRUVICA for cGVHD patients 12 years and older is 420 mg, taken orally once daily.
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