In a new glimmer of hope for cancer patients, the U.S. Food and Drug Administration's (FDA) accelerated approval program aims to give patients the opportunity to try promising drugs as quickly as possible. Meanwhile, questions arise about whether these drugs can improve patients' lives or prolong them. A recent study concluded that most cancer drugs that received accelerated approval do not show such benefits within five years, according to a report by the Associated Press.
Do they work or not? Dr. Ezekiel Emanuel, a cancer specialist and bioethics expert at the University of Pennsylvania, who did not participate in the research, stated, "After five years of initial accelerated approval, you should have a definitive answer. Thousands are taking these drugs. It seems wrong if we don't know whether they are effective or not."
The new study found that 46 cancer drugs received accelerated approval between 2013 and 2017. The program allows the FDA to grant early approval for drugs showing promising preliminary results for treating debilitating or deadly diseases. In return, pharmaceutical companies are expected to conduct rigorous testing and provide better evidence before obtaining full approval. Patients can access these drugs early, but this comes with the trade-off that some drugs may never come to fruition. It is up to the FDA or the drug manufacturer to withdraw disappointing drugs.
While 63% of these approvals were converted to regular approvals, only 43% showed clinical benefit in confirmatory trials. The research was published in the Journal of the American Medical Association and discussed during the annual meeting of the American Association for Cancer Research in San Diego on Sunday. It is noted that the program was established in 1992 to expedite access to HIV drugs. Today, 85% of accelerated approvals are for cancer drugs.
