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FDA ONCOLOGIC DRUG EFFICACY ENDPOINTS WILL BE REVIEWED

Executive Summary

FDA ONCOLOGIC DRUG EFFICACY ENDPOINTS WILL BE REVIEWED separately on a tumor-by-tumor basis, FDA Office of Drug Research & Review Director Robert Temple, MD, noted at the National Cancer Institute (NCI) Division of Cancer Treatment Board of Scientific Counselors' meeting on Oct. 2. Temple said the review would begin with consideration of efficacy endpoints in ovarian cancer, to be discussed at FDA's next Oncologic Drugs Advisory Committee meeting in December. "We believe strongly that there does need to be further public discussion of what the appropriate endpoints of therapy ought to be and will initiate a series of such discussions at the December meeting of the oncology advisory committee," Temple said. "These discussions will focus on particular tumor types, and we intend that ovarian cancer will be the first one, because we believe the specific criteria probably will not be identical for all tumor types." Temple made his remarks during an NCI session dedicated to FDA policy regarding approval of cancer drugs. In introductory remarks, NCI Division of Cancer Treatment Director Bruce Chabner, MD, explained that the session was prompted by NCI concern over FDA's rejection of Lederle's Novantrone NDA for breast cancer. Chabner expressed concern that FDA is using too stringent efficacy requirements (e.g., survival data) for reviewing cancer drugs. "We feel that a full and frank discussion of the criteria of approval at this point can avoid misunderstandings about the yardsticks that will be employed in deciding the fate of these drugs," Chabner explained. "Particularly, will survival data be the primary criterion for approval or will other parameters such as signficant improvement in remission rates, relief of symptoms, lesser toxicity in comparison to standard therapies, or others with accepted valid endpoints?" Temple commented that the agency does not require survival data for approval of cancer drugs. Temple specifically cited palliative response as an efficacy parameter FDA will accept for the approval of oncologic agents. "Despite the impression that some have, we . . . have not considered survival to be the sole endpoint for assessing the effectiveness of a new anticancer agent," Temple said. "We, in fact, consider all the standard endpoints that are measured in addition to survival, such as [tumor] response rate, duration of response, time to tumor progression, and any other evidence that can be brought forth of clinical meaningful benefit," Temple explained. "Palliation is a perfectly good endpoint," Temple said. "We do not see studies that report palliation; I don't know why that is, but we don't." Temple noted that he "floated the suggestion [before the Oncologic Drugs Advisory Committee] . . . that more attention be paid to unequivocal tumor related symptoms as a possible way of looking at drug effectiveness where survival is not influenced." The suggestion, Temple said, "was met with relatively little enthusiasm . . . but it seems to me that that's an area of great possibility." FDA Commissioner Young pledged to return to the board with the agency's strategy for review of cancer drugs and methods for improving industry/NCI input into the approval process. Young said, "Within six months, I will share with you the following things: One, our strategy for review of the oncology program . . .; Second, we will determine a process whereby we can enlarge your input into the analysis of what is forthcoming; Third, we will determine what type of interaction between FDA, NCI, industry, and academe can best provide the data for us for guidance, and this will be evaluated by our advisory committee; And, finally, I will explore to what extent we should utilize already an innovation which we've put forward, a drug board that has been established recently . . . at the Institute of Medicine."
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