Paper Details

  1. Home
  2. Paper Details

Clinical Trials Portfolio and Regulatory History of Idelalisib in Indolent Non-Hodgkin Lymphoma: A Systematic Review and Meta-analysis.

Author: BanerjeeTitas, HaslamAlyson, KimMyung Sun, PrasadVinay

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

This study describes the history of idelalisib, a phosphatidylinositol 3-kinase inhibitor that received accelerated approval for relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) but was later withdrawn due to serious adverse effects.
Paper Details　
Original Abstract of the Article :
Idelalisib is a first-in-class phosphatidylinositol 3-kinase inhibitor that received US Food and Drug Administration accelerated approval in July 2014 as a single-agent treatment for relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL). Serious adverse effects were reported in 2016...See full text at original site
Dr.Camel IconDr.Camel's Paper Summary Blogラクダ博士について

ラクダ博士は、Health Journal が論文の内容を分かりやすく解説するために作成した架空のキャラクターです。
難解な医学論文を、専門知識のない方にも理解しやすいように、噛み砕いて説明することを目指しています。

* ラクダ博士による解説は、あくまで論文の要点をまとめたものであり、原論文の完全な代替となるものではありません。詳細な内容については、必ず原論文をご参照ください。
* ラクダ博士は架空のキャラクターであり、実際の医学研究者や医療従事者とは一切関係がありません。
* 解説の内容は Health Journal が独自に解釈・作成したものであり、原論文の著者または出版社の見解を反映するものではありません。


引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10028543/

データ提供：米国国立医学図書館（NLM）

The Rise and Fall of Idelalisib: A Journey Through Clinical Trials and Regulatory Decisions

This systematic review and meta-analysis traces the journey of idelalisib, a first-in-class phosphatidylinositol 3-kinase inhibitor, through clinical trials and regulatory processes. The authors examine the drug's development, approval, and eventual withdrawal from the market. The review delves into the clinical trials portfolio and regulatory history of idelalisib, highlighting the challenges and complexities of drug development and approval.

A Tale of Two Approvals

The review highlights the complexities of drug development and regulatory processes. Idelalisib initially received accelerated approval for treating relapsed follicular lymphoma and small lymphocytic lymphoma. However, serious adverse effects and subsequent termination of postmarketing registry trials led to the drug's eventual withdrawal from the market. This case study demonstrates the importance of ongoing monitoring and evaluation of drug safety and efficacy, even after initial approval.

Navigating the Shifting Sands of Drug Development

This review emphasizes the unpredictable nature of drug development. It's like traversing a vast desert, where the landscape constantly shifts with new findings and challenges. The study highlights the importance of careful consideration of both efficacy and safety, and the need for a comprehensive approach to drug development and evaluation.

Dr.Camel's Conclusion

This review provides a valuable case study of the challenges and complexities of drug development and regulatory processes. It underscores the importance of ongoing monitoring and evaluation, and the need for a comprehensive approach to drug safety and efficacy assessment. While idelalisib's journey ultimately ended in withdrawal, it serves as a reminder of the importance of continuous learning and adaptation in the field of drug development.

Date :
  1. Date Completed 2023-05-03
  2. Date Revised 2023-05-25
Further Info :

Pubmed ID

36939665

DOI: Digital Object Identifier

PMC10028543

Related Literature

Article Analysis
・Effects of idelalisib
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

This site uses cookies. Visit our privacy policy page or click the link in any footer for more information and to change your preferences.