FDA Extends Review Period for Syndax Pharmaceuticals' Leukemia Drug Revumenib
FDA Extends Review Period for Syndax Pharmaceuticals' Leukemia Drug Revumenib
Syndax Pharmaceuticals (NASDAQ:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for revumenib for the treatment of adults and pediatric patients with relapsed or refractory (R/R) KMT2Ar acute leukemia.
今天，製造抗癌療法創新的BioPharmaceutical公司Syndax Pharmaceuticals（納斯達克證券代碼：SNDX）宣佈，美國食品藥品監督管理局（FDA）已經批准了用於治療成人和兒童複發性或難治性（R/R）KMT2A急性白血病的活性物質revumenib的新藥申請（NDA）的處方藥用戶費公約（PDUFA）動作日期。
The FDA notified Syndax on July 26, 2024 that they required additional time to conduct a full review of supplemental information provided to the FDA in response to their requests. The submission of additional information to the FDA was determined to constitute a Major Amendment to the NDA and resulted in a standard three-month extension to the original PDUFA action date of September 26, 2024. No additional trials or manufacturing information have been requested by the FDA.
FDA通知Syndax，需要額外的時間來對提交的補充信息進行全面審查。 根據FDA的要求提交的額外信息被確定爲NDA的重大修改，並導致PDUFA最初動作日期的標準3個月延期，截止日期爲2024年9月26日。 FDA未要求進行任何額外的試驗或製造信息。
