• The U.S. Food and Drug Administration approved the use of IMBRUVICA for the treatment of pediatric patients one year and older with cGVHD after failure of one or more lines of systemic therapy
  • This is the first approved treatment option for children with cGVHD under 12 years of age and the only Bruton’s tyrosine kinase inhibitor (BTKi) treatment for a pediatric patient population
  • cGVHD is a rare condition that can occur in patients after receiving peripheral blood or bone marrow stem cell transplantation often related to blood cancer treatment
  • IMBRUVICA was the first treatment approved in the U.S. in 2017 for adult patients with cGVHD after failure of one or more lines of systemic therapy

NORTH CHICAGO, Ill.Aug. 24, 2022 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (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 1/2 clinical trial.

Read complete press release HERE.