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Related Experiment Video

Updated: Feb 16, 2026

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[Let's go forward, but wisely…].

Massimo Di Maio1

  • 1Dipartimento di Oncologia, Università di Torino; SCDU Oncologia Medica, AO Ordine Mauriziano, Torino.

Recenti Progressi in Medicina
|January 4, 2018
PubMed
Summary

Most new anti-cancer drugs were approved without proven survival or quality-of-life benefits. This highlights the need for higher value standards in cancer drug approvals and development.

Area of Science:

  • Oncology
  • Health Economics
  • Drug Regulation

Background:

  • The sustainability of healthcare systems is threatened by the high cost of novel anti-cancer drugs.
  • A 2017 BMJ study analyzed anti-cancer drugs approved by the European Medicines Agency (EMA) from 2009-2013.
  • Most approved drugs lacked evidence of improved overall survival or quality of life.

Discussion:

  • There is a growing consensus among regulatory agencies, oncologists, and scientific societies on the need to "raise the bar" for treatment value.
  • The American Society of Clinical Oncology (ASCO) and European Society for Medical Oncology (ESMO) introduced treatment value frameworks in 2015.
  • These frameworks aim to objectively quantify the value of cancer therapies.

Key Insights:

  • A significant proportion of anti-cancer drugs approved between 2009 and 2013 did not demonstrate substantial clinical benefit in terms of survival or quality of life.

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  • The study underscores a critical gap between drug approval and proven patient benefit, raising concerns about healthcare resource allocation.
  • The findings emphasize the urgent need for more rigorous evaluation of anti-cancer drug efficacy.

    • Outlook:

    • Future analyses repeating the study for subsequent years are anticipated to reveal trends in the magnitude of treatment benefit.
    • Increased focus on treatment value is expected to drive the development and approval of more effective anti-cancer therapies.
    • The ongoing debate on the relevance of clinical trial results will likely intensify, necessitating a wiser approach to cancer drug advancement.