Company Resumes Marketing of Iclusig (Ponatinib) for Leukemia Patients
FDA okays revised prescribing information (December 21)
The FDA has approved revised U.S. prescribing information (USPI) and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig (ponatinib, Ariad Pharmaceuticals) that allows immediate resumption of the drug’s marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information, and recommendations regarding dosing considerations for prescribers.
Iclusig (pomatinib) is indicated for the treatment of adult patients with:
- T315I-positive chronic myeloid leukemia (CML) (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)
- Chronic phase, accelerated phase, or blast phase CML or Ph+ ALL for whom no other tyrosine-kinase inhibitor therapy is indicated
The boxed warning for Iclusig has been revised to alert health care professionals and patients to the risk of vascular occlusive events and includes a new warning for heart failure. The starting dose of Iclusig remains 45 mg daily.
Ponatinib is a tyrosine kinase inhibitor (TKI). The drug’s primary target is BCR-ABL, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL. Ponatinib was designed to inhibit the activity of BCR-ABL. The drug targets not only native BCR-ABL but also its isoforms, which carry mutations that confer resistance to treatment, including the T315I mutation, a common mutation that has been associated with resistance to other approved TKIs.
Source: Ariad Pharmaceuticals; December 21, 2013.