A new study reveals that less than half of the cancer drugs approved under the FDA's accelerated approval pathway have been shown to improve overall survival or quality of life, despite being on the market for more than 5 years.
SAN DIEGO — Fewer than half of the cancer drugs approved under the US Food and Drug Administration's accelerated approval pathway between 2013 and 2017 have been shown to improve overall survival or quality of life , despite being on the US market for more than 5 years, according to a new study.
The problem with relying on surrogate markers for drug approvals is that they don't always correlate with longer survival or improved quality of life, said Edward Cliff, MBBS, who presented the findings at the American Association for Cancer Research 2024 annual meeting . The study was also published in
The reliance on surrogate markers means that these drugs are used for treatment, covered by insurance, and added to guidelines — all without solid evidence of real-world clinical benefit, said Cliff. But the solution is not to curtail approvals; it's to make sure that accelerated approval commitments are met, said Kummar.
Cancer Drugs FDA Accelerated Approval Pathway Overall Survival Quality Of Life Confirmatory Trials
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