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The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020

Gloy, Viktoria (författare)
Univ Basel, Dept Clin Res, Basel, Switzerland.;Univ Hosp Basel, Basel, Switzerland.
Schmitt, Andreas M. (författare)
Univ Basel, Dept Clin Res, Basel, Switzerland.;Univ Hosp Basel, Basel, Switzerland.;Univ Hosp Basel, Dept Med Oncol, Basel, Switzerland.;Royal Marsden Hosp NHS Fdn Trust, Dept Med Oncol, London, England.
Dueblin, Pascal (författare)
Univ Basel, Dept Clin Res, Basel, Switzerland.;Univ Hosp Basel, Basel, Switzerland.
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Hirt, Julian (författare)
Univ Basel, Dept Clin Res, Basel, Switzerland.;Univ Hosp Basel, Basel, Switzerland.;Martin Luther Univ Halle Wittenberg, Inst Hlth & Nursing Sci, Int Grad Acad, Med Fac, Halle, Saale, Germany.;Eastern Switzerland Univ Appl Sci, Inst Nursing Sci, Dept Hlth, St Gallen, Switzerland.
Axfors, Cathrine (författare)
Uppsala universitet,Obstetrisk och reproduktiv hälsoforskning,Stanford Univ, Meta Res Innovat Ctr, Stanford METRICS, Stanford, CA USA.
Kuk, Hanna (författare)
Univ Ottawa, Dept Med, Ottawa, ON, Canada.
Pereira, Tiago V. (författare)
Univ Toronto, St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr AHRC, Toronto, ON, Canada.;Univ Leicester, Dept Hlth Sci, Leicester, Leics, England.
Locher, Clara (författare)
Univ Rennes, Inst Rech Sante Environm & Travail Irset, Ctr Invest Clin Rennes CIC1414, Serv Pharmacol Clin,CHU Rennes,Inserm, Rennes, France.
Caquelin, Laura (författare)
Univ Rennes, Inst Rech Sante Environm & Travail Irset, Ctr Invest Clin Rennes CIC1414, Serv Pharmacol Clin,CHU Rennes,Inserm, Rennes, France.
Walter-Claudi, Martin (författare)
Univ Hosp Basel, Dept Med Oncol, Basel, Switzerland.
Lythgoe, Mark P. (författare)
Imperial Coll London, Hammersmith Hosp, Dept Surg & Canc, London, England.
Herbrand, Amanda (författare)
Univ Hosp Basel, Dept Med Oncol, Basel, Switzerland.
Kasenda, Benjamin (författare)
Univ Hosp Basel, Dept Med Oncol, Basel, Switzerland.
Hemkens, Lars G. (författare)
Univ Basel, Dept Clin Res, Basel, Switzerland.;Univ Hosp Basel, Basel, Switzerland.;Univ Hosp Basel, Res Ctr Clin Neuroimmunol & Neurosci Basel RC2NB, Basel, Switzerland.;Univ Basel, Basel, Switzerland.;Berlin Inst Hlth, Meta Res Innovat Ctr Berlin METRIC B, Berlin, Germany.
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Univ Basel, Dept Clin Res, Basel, Switzerland;Univ Hosp Basel, Basel, Switzerland. Univ Basel, Dept Clin Res, Basel, Switzerland.;Univ Hosp Basel, Basel, Switzerland.;Univ Hosp Basel, Dept Med Oncol, Basel, Switzerland.;Royal Marsden Hosp NHS Fdn Trust, Dept Med Oncol, London, England. (creator_code:org_t)
2023-02-24
2023
Engelska.
Ingår i: International Journal of Cancer. - : John Wiley & Sons. - 0020-7136 .- 1097-0215. ; 152:12, s. 2474-2484
Relaterad länk:
https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

Nyckelord

drug approval
evidence-based medicine
health care policy
quality of life

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