Most cancer drugs fail to show benefits 5 years after accelerated approval.
Researchers have shed light on the efficacy of cancer drugs that have been granted accelerated approval by the U.S. Food and Drug Administration (FDA). This accelerated approval program was initially designed to provide early access to promising drugs for patients in need. However, the study’s findings have raised questions about the actual benefits of these drugs in improving or extending patients’ lives.
Dr. Ezekiel Emanuel, a prominent cancer specialist and bioethicist at the University of Pennsylvania, expressed the urgency of obtaining definitive answers about the effectiveness of these drugs within five years of their accelerated approval. He emphasized the potential risks associated with administering drugs to thousands of patients without clear evidence of their efficacy, stating, “Thousands of people are getting those drugs. That seems a mistake if we don’t know whether they work or not.”
Originally established in 1992 with a focus on expediting access to HIV drugs, the accelerated approval program has since evolved, with 85% of accelerated approvals now being granted to cancer drugs. This program allows the FDA to grant early approval to drugs showing promising initial results in treating debilitating or fatal diseases. In return, drug companies are expected to conduct comprehensive testing and produce substantial evidence before obtaining full approval.
However, the tradeoff of early access to medications means that some drugs may not yield the expected benefits. The responsibility falls on the FDA or the drugmakers to withdraw drugs that do not meet the expected standards. In some cases, the FDA has accepted less definitive evidence as sufficient for full approval.
