Jointly developed and commercialised by Pharmacyclics, Imbruvica (ibrutinib) is a once-daily oral medication that blocks the Bruton’s tyrosine kinase (BTK) protein.
The sNDA seeks approval for the drug to treat cGVHD paediatric and adolescent patients aged one year and above after the failure of one or more lines of systemic therapy.
The company has also submitted a new drug application (NDA) for an oral formulation of Imbruvica to offer as an alternative administration option for paediatric patients.
If approved, this marks AbbVie’s first pediatric indication for Imbruvica..
AbbVie Imbruvica Global Development lead and executive medical director James Dean said: “We are committed to this work with IMBRUVICA in the hopes of providing the first FDA-approved BTKi treatment option for younger patients with cGVHD, including a new oral suspension formulation.
“For young children, the availability of a liquid oral suspension versus an oral capsule or tablet can be significant to enable them to take the recommended dose and address challenges swallowing capsules or tablets.”
The sNDA and NDA submissions were supported with the findings obtained from the Phase I/II iMAGINE clinical trial, which was conducted in 59 paediatric patients aged between one and 19 years with relapsed/refractory (R/R) or new-onset moderate/severe cGVHD.
In the study, Imbruvica treatment has shown 78% overall response rate and the pharmacokinetic (PK) data was consistent with adult dosing.
The data also showed that the response rates were 70% of the treatment-naive patient population and 58% of the relapsed/refractory group after 20 weeks of treatment.