FDA approves Imbruvica for pediatric patients with cGVHD

On August 24, the US Food and Drug Administration announced it has approved Pharmacyclics application for Imbruvica (ibrutinib) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.

AbbVie (NYSE: ABBV) acquired the original development partner Pharmacyclics for $21 billion in 2015, and now markets Imbruvica under a collaboration with Johnson & Johnson (NYSE: JNJ) unit Janssen. J&J posted second-quarter 2022 Imbruvica sales of $970 million, down 13%, while AbbVie’s net revenues were $1.145 billion, a decrease of 17.1%.

The approval is AbbVie's first pediatric indication for Imbruvica, marking the 12th FDA approval for the drug and the first Bruton's tyrosine kinase inhibitor (BTKi) treatment approved for a pediatric patient population, the company noted in its own press release on the development. 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 I/II clinical trial.