AbbVie Seeks New Indication for Imbruvica in Pediatric Patients
AbbVie has filed for an expanded indication for its blockbuster Imbruvica (ibrutinib) as a treatment for chronic graft vs. host disease (cGVHD) in pediatric and adolescent patients who have undergone at least one line of prior therapy.
The supplemental New Drug Application was supported by a phase 1/2 study in 59 participants aged one to 19 years. The results showed an overall response rate of 78 percent and a pharmacokinetic profile consistent with that seen in adults.
If approved, this will be AbbVie’s first pediatric indication for Imbruvica. The drug, which was co-developed with Johnson & Johnson, was approved for treatment of adults with cGVHD in 2017.
To address swallowing issues in young children, AbbVie has also filed for approval for an oral suspension formulation as an alternative administrative option.