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FDA Approves Iclusig for Certain Types of CML, ALL

Ariad news release; 2016 Nov 29

The FDA has approved Iclusig (ponatinib) to treat certain types of chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Indications: Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase CML, or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

Dosage and administration: 45 mg taken orally once daily. For hepatic impairment, 30 mg orally once daily.

Efficacy and safety: Approval is based on data from the PACE trial, which showed that 55% of chronic phase CML patients achieved major cytogenetic response.

Side effects/risks: Most common adverse reactions are abdominal pain, rash, constipation, headache, dry skin, fatigue, hypertension, pyrexia, arthralgia, nausea, diarrhea, lipase increased, vomiting, myalgia and pain in extremity.


Ariad announces FDA full approval and label update for Iclusig® (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial. [news release]. Cambridge, MA: Ariad Pharmaceuticals November 29, 2016. Accessed December 5, 2016.

Iclusig [package insert]. Cambridge, MA: Ariad Pharmaceuticals, Inc 2016. Accessed December 5, 2016.