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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.

Citation:

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. http://www.businesswire.com/news/home/20161129005510/en/ARIAD-Announces-.... Accessed December 5, 2016.

Iclusig [package insert]. Cambridge, MA: Ariad Pharmaceuticals, Inc 2016. http://www.ariad.com/files/1914/8044/8671/Iclusig-Prescribing-Informatio.... Accessed December 5, 2016.

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