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FDA Approves Revised Prescribing Information for Ponatinib, Authorizes Resumption of Drug Sales and Distribution

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Key Points

  • FDA has approved revised prescribing information for ponatinib and a Risk Evaluation and Mitigation Strategy that allows immediate resumption of its marketing and commercial distribution
  • Commercial distribution of ponatinib will resume by mid-January. In the interim, patients will continue to receive the drug through the IND mechanism.

The U.S. Food and Drug Administration (FDA) has approved revised prescribing information and a Risk Evaluation and Mitigation Strategy (REMS) for ponatinib (Iclusig) that allows immediate resumption of its marketing and commercial distribution. The prescribing information includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers.

Revised Indication

Ponatinib is now indicated for the treatment of adult patients with T315I-positive chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or T315I-positive Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL), as well as patients with chronic-phase, accelerated-phase, or blast-phase CML or Philadelphia chromosome–positive ALL for whom no other tyrosine kinase inhibitor therapy is indicated.

The FDA granted approval of the revised prescribing information based on its review of the ponatinib clinical trial data, including 24-month follow up of the pivotal PACE trial. The boxed warning has been revised to alert patients and health-care professionals to the risk of vascular occlusive events and includes a new warning for heart failure. The starting dose of ponatinib remains 45 mg daily.

At the end of October 2013, there were approximately 640 patients receiving ponatinib obtained through commercial channels in the United States.  Since then, ponatinib has been made available through emergency and single-patient investigational new drug (IND) applications, which were reviewed and approved by the FDA on a case-by-case basis. Through today, FDA has approved 350 INDs.  This figure includes approximately 260 patients who have already received ponatinib and approximately 90 additional patients who have been approved to receive ponatinib through these mechanisms. 

“We are committed to continuing our productive collaboration with the FDA and to helping patients and their physicians make informed decisions about the most appropriate use of [ponatinib] in the context of the revised product label,” stated Frank Haluska, MD, PhD, Senior Vice President and Chief Medical Officer of Ariad.

Commercial distribution of ponatinib will resume by mid-January. In the interim, patients will continue to receive the drug through the IND mechanism.

REMS Program and Post-Marketing Requirements

The objective of the REMS program is to inform prescribers of the risk of vascular occlusion associated with ponatinib and of the revised indications.  The REMS program for ponatinib, which will be initiated within 3 weeks, will inform prescribers of the risk of vascular occlusion associated with ponatinib and of the revised indications. All materials sent to physicians and professional societies will be available on a ponatinib REMS website. 

In addition, ARIAD has agreed to fulfill a series of postmarketing requirements beginning in 2014 to better understand the risks of vascular occlusion and to further explore various doses of ponatinib.

Please see the full prescribing information for ponatinib, including the boxed warning, for additional important safety information.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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