快速通道透视：揭开美国食品药物管理局（USFDA）和欧洲药品管理局（EMA）批准和撤销肿瘤和非肿瘤药物的神秘面纱。

IF 5.5 2区医学 Q1 HEMATOLOGY

Critical reviews in oncology/hematology Pub Date : 2024-11-08 DOI:10.1016/j.critrevonc.2024.104539

Purva Dayanand Chaugule , Priya Changdev Varpe , Ankita Arun Tandulje , Rajeev Singh Raghuvanshi , Saurabh Srivastava

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引用次数: 0

摘要

背景：在药物进入市场之前，卫生部门会对已汇编的信息进行严格评估，从而推迟药物进入市场的时间。为解决这一空白，引入了快速通道：在这项研究中，我们利用美国食品药物管理局 2020-2023 年新药批准情况和欧洲药品管理局 2020-2023 年人类医药要闻，对美国和欧洲通过各种加速途径批准的肿瘤和非肿瘤药物进行了仔细研究。此外，还研究了药物撤回的情况以及导致药物撤回的因素：结果：在所有途径中，加速审批的肿瘤药物审批率较高，根据替代终点审批的药物撤回率也较高。从研究中可以看出，对于根据替代终点批准的药物，在批准前和批准后都必须进行强化评估，并对其进行确证试验。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Expedited pathway insights: Unveiling oncology and non-oncology drug approvals and withdrawals of USFDA and EMA

Background

Prior to entering the market, health authorities conduct a rigorous evaluation of compiled information for drugs delaying its entry. To address this void expedited pathways are introduced.

Methods

In this study, both oncology and non-oncology drugs approved through various expedited pathways from the US and Europe have been scrutinized using the USFDA’s Novel Drug approvals from 2020 to 2023 and EMA’s Human Medicine Highlights 2020 to 2023. Withdrawals if any along with factors causing withdrawal have also been studied.

Results

Among all the pathways accelerated approval has high oncological drug approvals and also high withdrawal for drugs approved based on surrogate endpoints. From the study conducted it was observed that intensive evaluation has to be performed both pre and post-approval for drugs approved based on surrogate endpoints as well as on the conduct of their confirmatory trials.

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来源期刊

Critical reviews in oncology/hematology 医学-血液学

CiteScore

11.00

自引率

3.20%

发文量

213

审稿时长

55 days

期刊介绍： Critical Reviews in Oncology/Hematology publishes scholarly, critical reviews in all fields of oncology and hematology written by experts from around the world. Critical Reviews in Oncology/Hematology is the Official Journal of the European School of Oncology (ESO) and the International Society of Liquid Biopsy.