Ponatinib in CML

FDA Approvals > Medscape Medical News

FDA Approves Ponatinib for Rare Leukemias

Zosia Chustecka

Disclosures Dec 14, 2012

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Ponatinib ( Iclusig, Araid) was approved today by the US Food and Drug Administration (FDA) for use in patients with 2 leukemias that have stopped responding to other therapies, and offers new hope for these subgroups of patients. The approval comes 2 months earlier than expected.
Ponatinib is approved for use in patients with chronic myeloid leukemia (CML) and also Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (Ph+ ALL) who have relapsed or are refractory to other therapies. Many of these patients, but not all, have developed a T3151 mutation, which makes the disease resistant to the standard treatment with tyrosine kinase inhibitors (TKIs) such as imatinib ( Gleevec).
"The approval of ponatinib is important because it provides a treatment option to patients with CML who are not responding to other drugs, particularly those with the T3151 mutation who have few therapeutic options," said Richard Pazdur, MD,