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FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.

Author: Al HakimAli, BlumenthalGideon M, BoydKaren, BrowerMargaret, FoxEmily, HelmsWhitney, JusticeRobert, KeeganPatricia, KhozinSean, LeongRuby, LiuQi, LuDonghao, PanYuzhuo, PazdurRichard, SongPengfei, TangShenghui, TangZhe, ZhangLijun, ZhaoHong, ZhaoPing

Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Overview

Ceritinib is a drug used to treat anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC). This article describes the FDA approval of ceritinib for the treatment of ALK-positive NSCLC. Ceritinib was found to be effective in treating this type of cancer, with an objective response rate of 44%.
Paper Details　
Original Abstract of the Article :
On April 29, 2014, the FDA granted accelerated approval to ceritinib (ZYKADIA; Novartis Pharmaceuticals Corporation), a breakthrough therapy-designated drug, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progresse...See full text at original site
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引用元：
https://doi.org/10.1158/1078-0432.CCR-14-3157

データ提供：米国国立医学図書館（NLM）

FDA Approval of Ceritinib for Metastatic Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

This research examines the significant development of [ceritinib (ZYKADIA)], a breakthrough therapy for patients with [anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)]. The study focuses on the FDA approval of [ceritinib] for the treatment of patients who have progressed on or are intolerant to [crizotinib]. The researchers present data from a [single-arm multicenter trial] that evaluated the efficacy and safety of [ceritinib] in this patient population. Their findings demonstrate the potential of [ceritinib] as a valuable treatment option for individuals with this aggressive form of lung cancer.

Ceritinib Offers Hope for ALK-Positive NSCLC Patients

This study provides compelling evidence for the effectiveness of [ceritinib] in treating [anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)]. The researchers found an [objective response rate (ORR)] of [44%] in patients who had progressed on or were intolerant to [crizotinib]. This indicates that [ceritinib] can significantly reduce tumor size and potentially improve survival outcomes for these patients. The study also highlights the relatively favorable safety profile of [ceritinib] despite the need for dose adjustments in some patients.

Ceritinib: A New Weapon in the Fight against Lung Cancer

This study represents a significant step forward in the treatment of [anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)]. The FDA approval of [ceritinib] provides patients with a new and potentially effective treatment option. The findings underscore the importance of targeted therapies in treating cancer and offer hope for improved outcomes for individuals with this aggressive form of lung cancer.

Dr. Camel's Conclusion

This research highlights the transformative power of targeted therapies in treating cancer. The FDA approval of [ceritinib] for [anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)] is a testament to the ongoing progress in cancer research and the development of more effective treatments. As a researcher, I am heartened by the continued efforts to improve patient outcomes and offer hope for a future where cancer is no longer a death sentence.
Date :
  1. Date Completed 2016-02-22
  2. Date Revised 2022-03-30
Further Info :

Pubmed ID

25754348

DOI: Digital Object Identifier

10.1158/1078-0432.CCR-14-3157

Related Literature

Article Analysis
・Side Effects of ceritinib
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.

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