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Inside ODAC’s Vote on Sotorasib in Advanced and Metastatic NSCLC: Lessons Learned
Manage episode 407461991 series 3560609
内容由Jacqueline Stone and Oncololgy News Central提供。所有播客内容（包括剧集、图形和播客描述）均由 Jacqueline Stone and Oncololgy News Central 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品，您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
Last month, a U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) determined that progression-free survival (PFS) could not be reliably interpreted in a confirmatory clinical trial for sotorasib (Lumakras) used to treat KRAS G12C–mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Ravi A. Madan, MD, senior clinician at the National Cancer Institute’s Center for Cancer Research and chair of the ODAC, speaks with Robert A. Figlin, MD, the Steven Spielberg Family Chair in Hematology-Oncology at Cedars-Sinai Cancer Center in Los Angeles, about broader implications from the 2-10 vote against the sotorasib data. They discuss the specific rationale behind the decision, as well as what this means for clinical practice in the short term and big picture solutions to help improve future trials.
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