Ariad Pharmaceuticals, Inc. : ARIAD Updates on U.S. Resumption of Marketing and Commercial Distribution of Iclusig (ponatinib) in Refractory Philadelphia- Positive Leukemias
01/03/2014 | 10:06pm US/Eastern
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ARIAD Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved revised U.S. Prescribing Information (USPI) and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig (ponatinib) that allows immediate resumption of its marketing and commercial distribution.
In a release, the company noted that the USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers.
Iclusig is now indicated for the treatment of adult patients with:
-T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, and
-Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated.
The FDA granted approval of the revised USPI based on its review of the Iclusig clinical-trial data, including 24-month follow up of the pivotal PACE trial. The boxed warning has been revised to alert patients and healthcare professionals to the risk of vascular occlusive events and includes a new warning for heart failure. The starting dose of Iclusig remains 45 mg daily.
"In less than two months of suspending marketing and commercial distribution of Iclusig in the U.S., we addressed the issues raised by the FDA and now are able to market and distribute Iclusig again in the U.S.," noted Harvey J. Berger, M.D. chairman and chief executive officer of ARIAD. "As we look ahead to re-launching Iclusig in the U.S. and fulfilling our post-marketing requirements, we will continue to focus on understanding the benefits and risks of Iclusig treatment in patients with resistant or intolerant Philadelphia-positive leukemias."
At the end of October 2013, there were approximately 640 patients receiving Iclusig obtained through commercial channels in the U.S. Since then, Iclusig 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. FDA has recently approved 350 INDs. This figure includes approximately 260 patients who have already received Iclusig and approximately 90 additional patients who have been approved to receive Iclusig 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 Iclusig in the context of the revised product label," stated Frank Haluska, M.D., Ph.D., senior vice president and chief medical officer of ARIAD.
"Commercial distribution of Iclusig will begin by mid-January at which time we will deploy dedicated commercial and medical affairs teams in the U.S. In the meantime, patients will continue to receive Iclusig through the IND mechanism," noted Marty Duvall, executive vice president and chief commercial officer. "We expect the commercialization of Iclusig to be cash-flow positive from the onset."
The objective of the REMS program is to inform prescribers of the risk of vascular occlusion associated with Iclusig and of the revised indications. The REMS program, which will be initiated within three weeks, includes letters to physicians and professional societies, a fact sheet and information that will be communicated through professional journals and displayed at scientific meetings. All of these materials will be available on an Iclusig REMS website.
In addition, ARIAD has agreed to fulfill a series of post- marketing requirements beginning in 2014 to better understand the risks of vascular occlusion and to further explore various doses of Iclusig, as follows:
-Enhanced pharmacovigilance assessment of risk factors for, and the management and consequences of, vascular occlusive events that are serious or require medical evaluation or treatment, occurring while patients are receiving Iclusig administered in clinical trials or obtained through commercial channels,
-Prospective observation of patients on Iclusig obtained through commercial channels to evaluate the incidence of, and risk factors for, vascular occlusive events when Iclusig is given with or without anticoagulant or antiplatelet agents,
-Continued follow-up of patients from the three ARIAD-sponsored trials of Iclusig in Philadelphia-positive leukemias to assess the long-term safety of Iclusig treatment, including the long-term risk of vascular occlusive events, and
-A randomized, multi-arm trial to characterize a range of Iclusig doses and to inform its safe use in patients with refractory, chronic-phase chronic myeloid leukemia.
Iclusig is a kinase inhibitor.
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an integrated global oncology company focused on transforming the lives of cancer patients with medicines.
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