FDA Approves Imbruvica for Potentially Serious Complication in Children With Cancer

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The FDA approved Imbruvica for children over the age of 1 who are experiencing chronic GVHD that has already been treated by one or more prior therapy.

The Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) for the treatment of children aged 1 year or older with chronic graft-versus-host disease (cGVHD) after one or more lines of systemic therapy, according to a news release from the agency.

The drug may be administered via capsules, tablets or oral suspension.

The approval is based off findings from the iMAGINE clinical trial, which included 47 patients between 1 and 22 years old who needed additional therapy after one or more prior treatments did not work for cGVHD.

The main goal of the study was to measure overall response rate (percentage of patients whose cGVHD improved) through week 25. At week 25, the overall response rate was 60%, with the average duration of response for patients given Imbruvica being 5.3 months. The average time from patient response to Imbruvica to death or a new systemic therapy was 14.8 months.

GVHD is a complication that is commonly seen after patients undergo stem cell or bone marrow transplantation — both treatments for various blood cancers — and is caused by the new donor cells being attacked by the transplant recipient’s body. When GVHD occurs or lasts 100 days or more after transplant, it is considered to be chronic.

Imbruvica was previously approved to treat chronic GVHD in adults in August 2017.

Common side effects that occurred in 20% or more of patients included: laboratory abnormalities, anemia, musculoskeletal pain, fever, diarrhea, pneumonia, abdominal pain, stomatitis (mouth sores), thrombocytopenia (decrease in white blood cells called thrombocytes) and headache.


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