MONDAY, Sept. 13, 2021 (HealthDay News) — Some cancer drugs that initially received accelerated approval have indications that remain on the labeling and are recommended in clinical guidelines, despite having failed to improve the primary end point in postapproval trials, according to a study published online Sept. 8 in The BMJ.
Bishal Gyawali, M.D., Ph.D., from Queen’s University in Kingston, Ontario, Canada, and colleagues conducted a retrospective observational study to examine the regulatory handling of cancer drugs that were granted accelerated approval by the U.S. Food and Drug Administration but failed to improve the primary end point in postapproval trials. A total of 18 indications for 10 cancer drugs were identified that received accelerated approval but failed to improve the primary end point.
The researchers found that 11 indications were voluntarily withdrawn by the manufacturer and one was revoked by the FDA (bevacizumab for breast cancer). Six of the 11 withdrawals occurred in 2021. The other six indications remain on the labels. For accelerated approval drugs that have failed postapproval trials, National Comprehensive Cancer Network guidelines provide a high level of endorsement (category 1 for one indication and category 2A for seven), sometimes even after the approval has been withdrawn or revoked.
“These findings reflect the lack of fulfilment of the compromise between speed and evidence that underpins the accelerated approval pathway,” the authors write.
One author disclosed financial ties to the pharmaceutical industry; a second author disclosed ties to the health insurance industry.
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