J&J and AbbVie's blockbuster BTK inhibitor scoops a pediatric indication in graft-versus-host disease
As J&J and AbbVie duke it out with AstraZeneca and other BTK competitors in chronic lymphocytic leukemia (CLL), the partners are celebrating a first for Imbruvica in a pediatric population.
Imbruvica won approval on Wednesday as a second-line treatment for chronic graft versus host disease (cGVHD) in children one year and older, a condition in which donor cells attack the recipient after a stem cell or bone marrow transplant. It affects between 52% and 65% of all children who receive allogeneic transplants, according to Janssen and AbbVie — and until now, there were no approved treatments for that age group.
“Imagine going through a transplant and then being told you have a moderate to severe chronic disease that can sometimes also be life-threatening,” principal investigator Paul Carpenter said in a news release. “If these children were between one and 12 and didn’t respond to steroid treatment, we didn’t have any rigorously studied treatment options — until now.”
The approval was based on data from the Phase I/II iMAGINE trial in patients 1 to 22 years old, which showed an overall response rate of 60% at week 25 and a median duration of response of 5.3 months, according to the FDA.
The most common adverse reactions included anemia, musculoskeletal pain, pyrexia, diarrhea, pneumonia, abdominal pain, stomatitis, thrombocytopenia and headache.
“The pediatric cGVHD community is a prime example of an underserved patient population with high unmet medical needs for whom Janssen is committed to developing life-saving therapies,” said Craig Tendler, global head of late-stage development, diagnostics and medical affairs in Janssen R&D’s hematology and oncology units, in a statement.
Imbruvica was first approved to treat cGVHD in the second-line adult population back in 2017. But before that, it snagged an accelerated approval in second-line MCL in 2013 and has since racked up a range of other indications.
Janssen and AbbVie are facing heat from AstraZeneca in CLL, where the rival pharma posted some long-term data from a head-to-head trial comparing Imbruvica to its own BTK inhibitor Calquence at ASCO last year. BeiGene is also positioning its Brukinsa in CLL, and Eli Lilly is recruiting for a head-to-head trial testing its LOXO-305 against Imbruvica, Calquence and Brukinsa in MCL.
Last summer, a Delaware district court upheld J&J and AbbVie’s patent exclusivity for Imbruvica, likely delaying generic competition until 2032.