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FDA Approves Oral Suspension Ibrutinib in Adults with CLL

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The Food and Drug Administration (FDA) approved an oral suspension of ibrutinib for adults with chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL / SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy on February 26, 2024.

This is a helpful expansion of the label as pediatric oral suspension was already approved for children over one year of age with chronic graft versus host disease, and both ibrutinib capsules and tablets have been approved for adults for many years.

This means there is now an approved BTK inhibitor for those with who have difficulties swallowing to treat their CLL / SLL and all the other indications.

Here is a link to the official press release: Johnson & Johnson Announces Expansion of IMBRUVICA® (ibrutinib) Label in the U.S. to Include Oral Suspension Formulation for Adult Patients in its Approved Indications.