Iclusig Approved for Rare Leukemias

FRIDAY Dec. 14, 2012 -- Iclusig (ponatinib) has been approved by the U.S. Food and Drug Administration to treat two rare forms of leukemia -- cancers of the blood and bone marrow.

The drug was sanctioned for adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), the FDA said Friday in a news release.

Iclusig blocks the effects of proteins that promote development of cancer cells, the agency said. The drug was granted accelerated approval following a single study of 449 people with either CML or Ph+ ALL.

The product's label will include a boxed warning that users are at heightened risk of blood clots and liver poisoning. More common but less serious clinical side effects included high blood pressure, rash, abdominal pain, fatigue, headache, dry skin, constipation, fever, joint pain and nausea.

Iclusig is marketed by Ariad Pharmaceuticals, based in Cambridge, Mass.

More information

The FDA has more about this approval.

Posted: December 2012


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