Leukemia Research Foundation News

FDA Approves Iclusig Plus Chemo for Ph+ ALL

The Food and Drug Administration recently granted an accelerated approval to Iclusig (ponatinib), described as the new “standard of care” for adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL).

The Agency reported that the recommended Iclusig dose is 30 milligrams orally daily with a reduction to 15 milligrams orally daily after achieving MRD-negative CR at the end of induction, and patients can continue Iclusig with chemotherapy for up to 20 cycles until loss of response or unacceptable toxicity.

Previously, in 2020, the FDA had approved a supplemental new drug application for Iclusig for patients with chronic-phase chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.

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