Literature DB >> 34236432

The Oncologic Drugs Advisory Committee Votes of April 2021-Implications for the Fate of Accelerated Approval.

Kerrington Powell1, Mark P Lythgoe2, Vinay Prasad3.   

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Year:  2021        PMID: 34236432     DOI: 10.1001/jamaoncol.2021.3046

Source DB:  PubMed          Journal:  JAMA Oncol        ISSN: 2374-2437            Impact factor:   31.777


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  5 in total

1.  The FDA's latest move to expand eligibility for oncology trials - a double-edged sword?

Authors:  Mark P Lythgoe; Vinay Prasad
Journal:  Nat Rev Clin Oncol       Date:  2021-12       Impact factor: 66.675

2.  Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.

Authors:  Mark P Lythgoe; Aakash Desai; Bishal Gyawali; Philip Savage; Jonathan Krell; Jeremy L Warner; Ali Raza Khaki
Journal:  JAMA Netw Open       Date:  2022-06-01

3.  Duration of treatment in oncology clinical trials: does the duration change when the same drug moves from the experimental arm to the control arm?

Authors:  A Haslam; T Olivier; R Thawani; V Prasad
Journal:  ESMO Open       Date:  2022-04-22

4.  FDA Accelerated Approval for Malignant Hematology and Oncology Indications in the Canadian Environment.

Authors:  Cheryl Ho; Howard J Lim; Dean A Regier
Journal:  Curr Oncol       Date:  2022-01-18       Impact factor: 3.677

5.  The approval and withdrawal of melphalan flufenamide (melflufen): Implications for the state of the FDA.

Authors:  Timothée Olivier; Vinay Prasad
Journal:  Transl Oncol       Date:  2022-02-20       Impact factor: 4.243

  5 in total

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