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Clarification of the FDA Accelerated Agnostic Approval of Pembrolizumab and the Opportunities Arising From the Required Confirmatory Studies

Clarification of the FDA Accelerated Agnostic Approval of Pembrolizumab and the Opportunities... Letters ule; this is clearly not acceptable. Among exclusion criteria, the We disagree with the assertion that patients in this trial neuropathy rate was not reported, although many patients re- were treated inadequately. In fact, a similar percentage of pa- cruited may have previously received potentially neurotoxic tients in MITO-11 on the pazopanib arm discontinued therapy treatments. And in fact, neuropathy turned out to be the main prior to progression (approximately 30%), mostly related to ad- cause of interruption of treatment with paclitaxel and per- verse events. We did allow patients to have nonweekly pacli- haps also with the combination of pazopanib and paclitaxel. taxel for recurrent disease—as did the authors of MITO-11. Pa- Therefore, we do not have sufficient evidence to assess whether clitaxel administered weekly is believed to have different the combination of pazopanib with a weekly paclitaxel sched- mechanisms of action in the tumor microenvironment than ule is preferable to paclitaxel alone in terms of efficacy and paclitaxel administered every 3 weeks and is supported by sev- safety. eral phase 2 and phase 3 clinical trials demonstrating efficacy in patients whose disease has progressed during paclitaxel 3,4 Federica Tomao, MD, PhD therapy administered every 3 weeks. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Oncology American Medical Association

Clarification of the FDA Accelerated Agnostic Approval of Pembrolizumab and the Opportunities Arising From the Required Confirmatory Studies

Sorscher, Steven
JAMA Oncology , Volume 4 (9) – Sep 5, 2018
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Publisher
American Medical Association
Copyright
Copyright 2018 American Medical Association. All Rights Reserved.
ISSN
2374-2437
eISSN
2374-2445
DOI
10.1001/jamaoncol.2018.1709
Publisher site
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Abstract

Letters ule; this is clearly not acceptable. Among exclusion criteria, the We disagree with the assertion that patients in this trial neuropathy rate was not reported, although many patients re- were treated inadequately. In fact, a similar percentage of pa- cruited may have previously received potentially neurotoxic tients in MITO-11 on the pazopanib arm discontinued therapy treatments. And in fact, neuropathy turned out to be the main prior to progression (approximately 30%), mostly related to ad- cause of interruption of treatment with paclitaxel and per- verse events. We did allow patients to have nonweekly pacli- haps also with the combination of pazopanib and paclitaxel. taxel for recurrent disease—as did the authors of MITO-11. Pa- Therefore, we do not have sufficient evidence to assess whether clitaxel administered weekly is believed to have different the combination of pazopanib with a weekly paclitaxel sched- mechanisms of action in the tumor microenvironment than ule is preferable to paclitaxel alone in terms of efficacy and paclitaxel administered every 3 weeks and is supported by sev- safety. eral phase 2 and phase 3 clinical trials demonstrating efficacy in patients whose disease has progressed during paclitaxel 3,4 Federica Tomao, MD, PhD therapy administered every 3 weeks.

Journal

JAMA Oncology – American Medical Association

Published: Sep 5, 2018

References

  • Cancer drugs approved based on biomarkers and not tumor type—FDA approval of pembrolizumab for mismatch repair-deficient solid cancers
    Prasad, V; Kaestner, V; Mailankody, S
  • First FDA approval agnostic of cancer site—when a biomarker defines the indication
    Lemery, S; Keegan, P; Pazdur, R
  • Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden
    Chalmers, ZR; Connelly, CF; Fabrizio, D