Posted on May 29, 2019
Cancer Drugs Approved Quickly Often Fail To Measure Up Later
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Cancer drugs that speed onto the market based on encouraging preliminary studies often don't show clear benefits when more careful follow-up trials are done, according to research published Tuesday.
These cancer drugs are granted accelerated approval to give patients faster access to the treatments and to allow drug companies to reap the economic rewards sooner. As a condition of this process, the Food and Drug Administration requires drug companies to conduct more research, to confirm whether the medications actually work and are safe.
In 2018, the FDA looked back on 93 cancer drugs granted accelerated approval and touted that only five had been removed from the market over a 25-year span. A research team at Harvard Medical School's Program on Regulation, Therapeutics and Law dug deeper to see what had happened with the rest.
In the follow-up studies, only 19 of the 93 drugs clearly extended the lives of the patients taking them, according to the study, published in the latest JAMA Internal Medicine.
For example, Genentech's Avastin, or bevacizumab, won accelerated approval to treat the deadly brain cancer glioblastoma, but the drug did not extend the lives of patients in a follow-up study.
These cancer drugs are granted accelerated approval to give patients faster access to the treatments and to allow drug companies to reap the economic rewards sooner. As a condition of this process, the Food and Drug Administration requires drug companies to conduct more research, to confirm whether the medications actually work and are safe.
In 2018, the FDA looked back on 93 cancer drugs granted accelerated approval and touted that only five had been removed from the market over a 25-year span. A research team at Harvard Medical School's Program on Regulation, Therapeutics and Law dug deeper to see what had happened with the rest.
In the follow-up studies, only 19 of the 93 drugs clearly extended the lives of the patients taking them, according to the study, published in the latest JAMA Internal Medicine.
For example, Genentech's Avastin, or bevacizumab, won accelerated approval to treat the deadly brain cancer glioblastoma, but the drug did not extend the lives of patients in a follow-up study.
Cancer Drugs Approved Quickly Often Fail To Measure Up Later
Posted from npr.org
Cancer
Research
Drugs
Pharmaceuticals
Posted >1 y ago
Responses: 2
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Given a negative outlook, the acceleration of the drugs to market for what is effectively public trials is justified. This would not be acceptable when a disease is not life threatening.
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I fully understand the need for full clinical trials and years to get it right but Cancer pharmaceutical companies are in it for the money and therefore if they can show "promise" based on some small studies people will sign up in droves whether it has been fully tested over time or not. I am convinced that there is a cure for cancer out there but it is being squashed because so many people (doctors, clinics, and pharmaceutical companies) are making sick money on cancer treatments that ultimatley don't cure but extend. I just wish they would release the cure and heal people versus stringing them out and taking their last dime leaving their families penniless from hope that was crushed by promises made to cure.
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