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Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations
ASCO VF ESMO MCBS gastrointestinal malignancies anticancer drugs

Anticancer drugs approved by the Food and Drug Administration for gastrointestinal malignancies: Clinical benefit and price considerations


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Summary

  • Drugs approved between 2006 and 2017 were analyzed.
  • Clinical benefit was measured using ESMO Magnitude of Clinical Benefit Scale and ASCO Value Framework.
  • 16 GI cancer drugs received FDA approval for 24 indications, including various drug classes such as monoclonal antibodies, oral targeted therapies, immunotherapeutics, cytotoxic chemotherapies, and recombinant fusion proteins.
  • 82% of supporting trials reported an overall survival benefit of less than 3 months with no significant improvement in quality of life.
  • Only 21% of the approved indications met ESMO's threshold for substantial clinical benefit.
  • Median total drug price (TDP) for oral targeted therapies and immunotherapeutics was significantly higher compared to cytotoxic chemotherapies.
  • The TDP did not correlate with clinical benefit scores.

By 2020, the cost of cancer care in the United States is expected to reach $158 billion US dollars.1 Pharmaceutical drugs are the fastest growing aspect of US health care spending, with oncology treatments amounting to nearly $37.8 billion in 2015. Over the past decade, the average monthly price of oncology drugs more than doubled, from $7 103 to $15 535 USD. Concerns arise as the unprecedented increase in price of new anticancer drugs seem disproportionate to the clinical benefit they produce.

To address the growing disconnect between clinical benefit and cost, various frameworks have been developed by organizations including the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO). The ASCO value framework (VF) was designed to standardize the assessment of value for new anticancer treatment to guide decision-making by physicians and patients. ESMO intends to use the Magnitude of Clinical Benefit Scale (MCBS) to select anti-cancer therapies that offer the greatest benefit, and prioritize their drug funding across the European Union. Notably, more than half of the accelerated US Food and Drug Administration (FDA) approval indications of new anticancer drugs were based on single–arm studies and could no t be assessed with the original ESMO MCBS; however these can now be evaluated with ESMO MCBS version 1.1...

 

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ASCO VF, ESMO MCBS, gastrointestinal malignancies, anticancer drugs,

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