US Pharm. 2013;38(1):7.
Silver Spring, MD—The FDA has approved Iclusig (ponatinib) to
treat adults with chronic myeloid leukemia (CML) and Philadelphia
chromosome–positive acute lymphoblastic leukemia (Ph+ ALL), two rare
blood and bone marrow diseases. The drug was approved more than 3 months
before the FDA was scheduled to complete its review of the drug
application. Iclusig, which blocks certain proteins that promote the
development of cancerous cells, is used to treat patients with CML or
Ph+ ALL that is resistant or intolerant to tyrosine kinase inhibitors.
The drug carries a black box warning noting the occurrence of blood
clots and liver toxicity. Some of the more common side effects in
clinical trials were high blood pressure, abdominal pain, and rash.
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