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FDA Oks AbbVie' Imbruvica For Treatment Of Pediatric Patients With Chronic Graft Versus Host Disease

AbbVie (ABBV) said that the U.S. Food and Drug Administration approved the use of Imbruvica or ibrutinib for the treatment of pediatric patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy.

It is the first approved treatment option for children with chronic graft versus host disease or cGVHD under 12 years of age and the only Bruton's tyrosine kinase inhibitor (BTKi) treatment for a pediatric patient population, AbbVie said in a statement.

Chronic graft versus host disease is a rare condition that can occur in patients after receiving peripheral blood or bone marrow stem cell transplantation often related to blood cancer treatment.

Imbruvica was the first treatment approved in the U.S. in 2017 for adult patients with cGVHD after failure of one or more lines of systemic therapy.

The recommended dose of Imbruvica for cGVHD patients 12 years and older is 420 mg taken orally once daily until disease progression or unacceptable toxicity.

In cGVHD patients one year old to less than 12 years of age, the recommended dose of IMBRUVICA is 240 mg/m2 taken orally once daily (up to a dose of 420 mg) until disease progression or unacceptable toxicity.

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