FDA Drug Safety Changes Will Not Affect Oncology Therapies, Agency's Pazdur Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's safety overhaul "will not tamper with" drugs for life-threatening conditions, Office of Oncology Drug Products Director Pazdur tells the American Society of Clinical Oncology annual meeting. FDAer suggests the cancer community could provide insight into improved safety surveillance.
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Potential changes to FDA's safety review practices will not affect oncology therapies, Office of Oncology Drug Products Director Richard Pazdur said at the American Society of Clinical Oncology annual meeting in Orlando, Fla. May 14. The director of the new oncology office indicated that cancer drugs would not be subject to ramped-up safety measures that are resulting from efforts to overhaul FDA's regulation of drug safety. "For oncology drugs, the intent is not to tamper with the current process that we have," Pazdur said during a panel discussion on safety regulation. "In general, it is believed that if any changes occur in this arena, it is unlikely to impact short-term treatment such as antibiotics or drugs for serious [diseases] such as oncology and AIDS." "If there are any changes, it will be in the evaluation of long-term therapies for non-life threatening systemic modifications," he said. "We have to look at oncology differently when we look at risk-benefit relationships," Pazdur said. He noted that toxicities for oncology agents are accepted by health care providers and patients, and studies are designed to determine the maximum tolerated doses. Because of the pressures to provide access to drugs for life-threatening diseases, many of the current safety standards are not applicable to cancer agents, Pazdur said. "We have a rush to get these drugs out on the market for a life-threatening condition. We have accelerated approval, we have a need [for] expediency here to get the drugs to market." "We shouldn't underestimate [demand] for faster access" to oncology drugs, he added. Single-arm studies are frequently used for cancer therapies, especially for accelerated approval, and such studies "do not...adequately characterize certain toxicities that might be ascribed to the disease process itself." He also noted that oncology studies yield less patient exposure than studies for other drugs, because fewer patients are studied and many patients leave a trial early because of disease progression. The best way to improve the risk-benefit ratio in oncology is through targeted therapies and patient selection, FDA's top oncologist suggested. "The major advance in any risk-benefit analysis will be led by a greater scientific understanding of patient selection by decreasing the number of patients who are most likely to be harmed and increasing the number who are most likely to benefit from the drug," he said. Targeted therapies are a major theme of the annual oncology meeting, with a particular focus on identifying appropriate patient populations for targeted oncologics such as AstraZeneca's Iressa (see 1 (Also see "AstraZeneca's Iressa Produces Effect In Subpopulation, ASCO Data Show" - Pink Sheet, 16 May, 2005.) ). Pazdur said that approaches to improving safety regulation, such as creation of a Drug Safety Oversight Board or establishing a separate safety center, "aren't going to address the science that is required to change the risk-benefit ratio that can only be accomplished by identifying only those patients who are most likely to be helped." FDA recently outlined the responsibilities of its Drug Safety Oversight Board and provided details about the types of information that will be included on the new "Drug Watch" website (2 (Also see "FDA "Drug Watch" Website To Include Three Categories Of Safety Information" - Pink Sheet, 5 May, 2005.)). Pazdur also suggested the oncology arena could provide insight into redesigning the safety system. "Medical oncology provides unique resources for safety evaluation, and I do not think that these resources have been adequately tapped," he said. "Oncology has a unique opportunity should we decide to study safety better, and this would make us utilize our workforce that are very well trained to treat toxicity." "We have a clinical trial structure of cooperative groups of cancer centers…which could aid and assist in developing post-approval registries and post-approval marketing studies," he added. - Turna Ray, Mary Jo Laffler |