FDA NEWS
Clinical Oncology News • February 2012
Classwide TIRF REMS Approved T he FDA has approved a single shared risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products. According to an FDA press release, the new shared REMS will replace the individual REMS for this class of medications, which includes Abstral (fentanyl sublingual tablets; ProStrakan), Actiq (oral transmucosal fentanyl citrate; Cephalon), Fentora (fentanyl buccal tablet, Cephalon), Lazanda (fentanyl nasal spray; Archimedes), Subsys (fentanyl sublingual spray, Insys) and Onsolis (fentanyl buccal soluble film, Meda). All are opioid analgesics indicated for breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for underlying persistent cancer pain. Called the TIRF REMS
Einstein College of Medicine, New York City, said in an email. “The legislative mandate to have REMS programs will be much simpler to implement and more likely to lead to clinician practice change if it is created as a series of uniform take-home points that clinicians will see repeated each time they decide to prescribe a TIRF,” Dr. Portenoy said. “Of course, the details are critical, but we anticipate the mandatory education included in the classwide REMS for both the TIRF products and the long-acting opioids to be appropriate and necessary to advance safe prescribing.” According to the FDA, the goals of the TIRF REMS Access Program are to ensure patient access while mitigating risk by prescribing and dispensing TIRF medications only to appropriate patients; preventing inappropriate conversion between fentanyl formulations; preventing accidental exposure to those for whom TIRF drugs are not prescribed; and educating prescribers, pharmacists and patients on the potential for misuse, abuse, addiction and overdose. Until the TIRF REMS is launched, prescribers, pharmacies and patients should continue to enroll in the
individual REMS programs, according to the FDA. Prescribers and pharmacies already participating in an individual REMS program for at least one TIRF medication will automatically be transitioned to the new program. Clinicians who prescribe TIRF medications for use in an inpatient setting, and patients who receive them there, will not be required to enroll. The announcement of the TIRF REMS Access Program comes months after the September start of enrollment in the individual Actiq and Fentora REMS Program. Asked about the timing, Denise Bradley, vice president, Corporate Communications, Teva Pharmaceuticals, stated by email that even while the Actiq and Fentora REMS was being developed, “the FDA asked all sponsors of immediate-release fentanyl products to work together to develop a shared REMS.” —George Ochoa
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Access Program, the new shared system will begin in March. “This TIRF REMS will ensure safe use and access to these drugs for patients who need them,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in the press release. “We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the health care system.” The general concept of classwide REMS is one that clinicians should highly favor, Russell K. Portenoy, MD, chairman, Department of Pain Medicine and Palliative Care, Beth Israel Medical Center, and professor of neurology and anesthesiology, Albert
Correction Letter from the Editor:
I
n our January issue, the story “Pertuzumab: Practice-Changing for HER2+ Metastatic Breast Cancer” incorrectly referred to pertuzumab as having the trade name Omnitarg. According to Genentech, the company developing pertuzumab, at one time the compound did go by the trade name “Omnitarg,” but this name was discontinued by Genentech in 2007 because at the time, the compound was ultimately not approved by the FDA. No subsequent brand name has been assigned to date.
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Dr. Portenoy disclosed that in the past 12 months, he received an honorarium for speaking for Grupo Ferrer, which markets two TIRF products in Europe, and his department has received research grants from Archimedes Pharmaceuticals, Meda Pharmaceuticals and ProStrakan.
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