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Ibrutinib (IMBRUVICA; AbbVie) was approved by the US Food and Drug Administration for use in pediatric patients with chronic graft versus host disease.
The US Food and Drug Administration (FDA) has approved Iibrutinib (IMBRUVICA; AbbVie) for use in pediatric patients aged 1 year and above with chronic graft versus host disease (cGVHD). The treatment should be used after 1 or more lines of systemic therapy have failed.
This approval is the first pediatric indication for ibrutinib, the twelfth FDA approval for ibrutinib, and the first Bruton's tyrosine kinase inhibitor (BTKi) treatment approved for pediatric use. The approval is based on positive data from the iMAGINEphase 1/2 clinical trial.
Donated blood or bone marrow can register the recipient’s body as foreign. This causes cGVHD, a condition where the donated blood cells attack the body. Major organs are often affected, including the skin, eyes, mouth and liver.
Development of cGVHD which requires systemic treatment occurs in about 35% of life-saving allogeneic hematopoietic stem cell transplant a year. It is the most common condition to occur after an allogeneic transplant, and steroids are currently the most used form of treatment.
The approval of ibrutinib will give healthcare professionals another effective method of treating cGVHD in pediatric and adult patients, according to Paul A. Carpenter, MD.
An Overall Response Rate was seen in 60% of pediatric patients by week 25 in the iMAGINE study. Patients aged 1 year to less than 22 years old and diagnosed with moderate to severe cGVHDm were enrolled in the study. The 47 enrolled patients required additional treatment after 1 or more lines of systemic therapy had failed. Patients older than 12 years were given 420 mg orally per day, while patients younger than 12 years were given 240 mg orally per day.
Ibrutinib blocks the Bruton's tyrosine kinase (BTK) protein, helping abnormal B cells move out of their nourishing environments and inhibiting their proliferation. It has been used as treatment in over 250,000 patients worldwide and tested in over 50 clinical trials. The National Comprehensive Cancer Network recommends ibrutinib as initial treatment for CLL/SLL and for elapsed/refractory mantle cell lymphoma, giving ibrutinib category 1 treatment status for treatment-naïve patients without deletion 17p/TP53 mutation.
"This approval is incredibly meaningful as AbbVie's first pediatric approval for IMBRUVICA as well as within our company's oncology portfolio. As a pediatric oncologist, when my patients describe the physical pain they experience from simply hugging their parents due to their cGVHD, the importance of researching alternative treatment options in this patient population is further validated," said Gauri Sunkersett, DO, board certified physician in General Pediatrics and Pediatric Hematology/Oncology. "At AbbVie, we are committed to driving oncology research and developing therapies that have the potential to help patients of all ages, including underserved populations like children diagnosed with cGVHD."
Side effects of ibrutinib in pediatric patients include tiredness, low red blood cell count (anemia), bruising, diarrhea, low platelet count, muscle and joint pain, fever, muscle spasms, mouth sores (stomatitis), bleeding, nausea, stomach pain, pneumonia, and headache.
Patients should speak with a healthcare provider before taking ibrutinib if they have a recent or upcoming surgery, have bleeding problems, have or had heart rhythm problems, have an infection, have liver problems, are breastfeeding, or are pregnant.
Children with chronic graft versus host disease (cGVHD) may now be prescribed IMBRUVICA® (ibrutinib). Abbvie. August 24, 2022. Accessed August 25, 2022. https://news.abbvie.com/news/press-releases/children-with-chronic-graft-versus-host-disease-cgvhd-may-now-be-prescribed-imbruvica-ibrutinib.htm?view_id=5591