AbbVie’s Imbruvica (ibrutinib) Receives the US FDA’s Approval for Chronic Graft Versus Host Disease in Pediatric Patients Aged ≥1 Year


The US FDA has approved Imbruvica for cGVHD in pediatric patients aged ≥1yr. who required additional therapy after failure of ≥1 line of systemic therapy. The therapy is jointly developed & commercialized by Janssen & Pharmacyclics
The approval was based on the P-I/II (iMAGINE) trial evaluating Imbruvica (in 47 pediatric & young adult patients aged 1yr. to ≤22yrs. with cGVHD which showed ORR (60%) @25wk. in patients aged 13yrs., m-DoR was 5.3mos. The safety was consistent with the established profile for Imbruvica, ARs consistent with those observed in cGVHD
Imbruvica is a BTK inhibitor & was approved for a pediatric patient population. The therapy marks the first approved treatment option for children ≤12yrs. with cGVHD

Ref: PRNewswire | Image: AbbVie