According to a new study published in the Journal of the American Medical Association, some new anticancer drugs which appear to be promising and which obtain accelerated approvals, they don’t always work as hoped. In detail approximately 40% of anti-tumor therapiesi initiated through the FDA’s accelerated approval pathway, the Food and Drug Administration, between 2013 and 2017, did not show clinical benefits in follow-up studies performed five years later.
The FDA’s accelerated approvals program was created in response to the HIV and AIDS epidemics of the 1980s and 1990s, and has allowed early approval since 1992 of drugs that treat very serious conditions. It’s about a common practice is that of accelerated approval, especially in the case of cancer, given that a third of all oncology drug approvals go through the accelerated approval process, and over 80 percent of all accelerated approvals are granted for anticancer therapies, as specified by sciencealert .com.
57% ACCELERATED ANTI-CANCER DRUGS APPROVED DO NOT WORK: HOW IT WORKS
It is also true, however, that these “fast” approvals are based on surrogate markers of the effectiveness of a drug which it is believed to have a clinical benefit but without directly measuring the same. As for cancer drugs, they try to demonstrate that a patient can live longer with a given treatment, but “studies – specifies sciencealert.com – often use a surrogate measure of progression-free survival, that is, how long a person lives with cancer before it gets worse.”
Researchers at Brigham and Women’s Hospital in Boston analyzed accelerated FDA approvals of cancer drugs over the past decade, findings that had been criticized for using lower regulatory standards than traditional approvals
57% ANTI-CANCER DRUGS APPROVED ACCELERATEDLY DO NOT WORK: “THEY DO NOT EXTEND PATIENTS’ LIFE…”
“Although accelerated approval can be helpful, some cancer drugs do not end up demonstrating benefits in extending patients’ lives or improving their quality of life,” the epidemiologist said. Ian Liu as well as his colleagues in their article published in the aforementioned newspaper. 59 cancer drugs received provisional approval from the FDA between 2013 and 2023 indicated for 129 indications or more. As of mid-2023, for 46 indications, results are still pending for 7 medicines, while 10 medicines had been withdrawn.
Above all 41 percenttherefore 19 out of 46 who were granted accelerated approval in that period, it did not prolong patients’ lives or improve them, as the researchers discovered. If you add the 7 pending drugs, the figure then rises to 57 percent of fast-tracked cancer drugs showing no benefit five years after approval. An undoubtedly not positive situation, especially for those who are being treated with certain drugs, hoping to live a better life.
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