By PPN News Staff
The FDA granted a new indication to ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients who are 12 months of age and older with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. The new formulations include capsules, tablets and oral suspension.
This is the first pediatric indication for ibrutinib.
The FDA decision was based on iMAGINE (ClinicalTrials.gov Identifier: NCT03790332), an open-label, multicenter, single-arm