Accelerated Approval Standards Will Be Advisory Committee Topic In March
Executive Summary
FDA is planning an advisory committee meeting to discuss the accelerated approval process for oncologic agents
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FDA is planning an advisory committee meeting to discuss the accelerated approval process for oncologic agents. The agency is understood to have scheduled a meeting of the Oncologic Drugs Advisory Committee for March 12-13 to review the experience with and concerns about the application of Subpart H to oncology reviews. The oncology division has indicated that it wants to revisit the accelerated approval regs as they apply to anticancer drugs (1 (Also see "FDA May Revisit Accelerated Approval For Oncology Products" - Pink Sheet, 21 Oct, 2002.), p. 7). The agency is understood to have requested that all companies with oncologic products that have received accelerated approval make brief presentations to the committee detailing the basis for approval and the status of confirmatory trials. The committee could discuss the marked difference in the accelerated approval experience between oncology products and HIV products. Most HIV treatments approved under the accelerated approval regs have gone on to show clinical benefit in the follow-up studies required by the regulation. However, only four of 15 oncology products approved under Subpart H have completed studies to demonstrate full clinical benefit. Center for Drug Evaluation & Research Office of Medical Policy Director Robert Temple, MD, chaired a special scientific rounds session on accelerated approval Dec. 11. Representatives from the antiviral and oncology divisions presented. Other topics the committee could address include whether oncology accelerated approvals are based on the appropriate surrogate markers. The oncology division is reevaluating clinical endpoints for anticancer drug trials (2 , p. 8). ODAC also could assess whether accelerated approval should follow the model of approval for Sanofi-Synthelabo's Eloxatin (oxaliplatin), which was based on an interim analysis of a randomized Phase III study, rather than on a smaller, uncontrolled Phase II trial (3 (Also see "Sanofi Eloxatin First-Line Colorectal Cancer Data Will Be Submitted By 2003" - Pink Sheet, 19 Aug, 2002.), p. 5). |