Literature DB >> 29197081

Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology.

Jan Trøst Jørgensen1, Maria Hersom2.   

Abstract

Nearly 20 years have passed since the US Food and Drug Administration (FDA) approved the first companion diagnostic and today this type of assay governs the use of 21 different anticancer drugs. The regulators deem these assays essential for the safe and effective use of a corresponding therapeutic product. The companion diagnostic assays are important both during the drug development process as well as essential treatment decision tools after the approval of the drugs.
© 2017 American Society for Clinical Pharmacology and Therapeutics.

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Year:  2017        PMID： 29197081     DOI： 10.1002/cpt.955

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  9 in total

1.  Companion and complementary diagnostics for first-line immune checkpoint inhibitor treatment in non-small cell lung cancer.

Authors:  Jan Trøst Jørgensen; Karsten Bork Nielsen
Journal:  Transl Lung Cancer Res       Date:  2018-04

2.  Making the right calls in precision oncology.

Authors:  Kathryn D Bungartz; Kristen Lalowski; Sheryl K Elkin
Journal:  Nat Biotechnol       Date:  2018-08-06       Impact factor: 54.908

3.  Twenty Years with Personalized Medicine: Past, Present, and Future of Individualized Pharmacotherapy.

Authors:  Jan Trøst Jørgensen
Journal:  Oncologist       Date:  2019-04-02

4.  Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency.

Authors:  Marc Maliepaard; Priscilla Nibi; Gabrièlla Nibi; Anna M G Pasmooij
Journal:  Front Med (Lausanne)       Date:  2022-05-06

5.  Closed system RT-qPCR as a potential companion diagnostic test for immunotherapy outcome in metastatic melanoma.

Authors:  Swati Gupta; Leena McCann; Yvonne G Y Chan; Edwin W Lai; Wei Wei; Pok Fai Wong; James W Smithy; Jodi Weidler; Brian Rhees; Michael Bates; Harriet M Kluger; David L Rimm
Journal:  J Immunother Cancer       Date:  2019-09-18       Impact factor: 13.751

Review 6.  Changes in Companion Diagnostic Labelling: Implementation of FDA's April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups.

Authors:  Lisa Cooper; Joyce Chen
Journal:  Ther Innov Regul Sci       Date:  2022-06-10       Impact factor: 1.337

7.  A retrospective analysis of actionable pharmacogenetic/genomic biomarker language in FDA labels.

Authors:  Shinji Yamazaki
Journal:  Clin Transl Sci       Date:  2021-04-09       Impact factor: 4.689

Review 8.  [BRAF-V600E testing in metastatic colorectal cancer and new, chemotherapy-free therapy options. German version].

Authors:  Michael Hummel; Susanna Hegewisch-Becker; Jens Neumann; Arndt Vogel
Journal:  Pathologe       Date:  2021-05-06       Impact factor: 1.011

Review 9.  BRAF testing in metastatic colorectal carcinoma and novel, chemotherapy-free therapeutic options.

Authors:  Michael Hummel; Susanna Hegewisch-Becker; Jens H L Neumann; Arndt Vogel
Journal:  Pathologe       Date:  2021-07-14       Impact factor: 1.011
  9 in total

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