In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and were later withdrawn due to negative confirmatory trials, more than one quarter of patients with breast, bladder, hepatocellular, gastric, or small cell lung cancer received an AA drug rather than standard of care, according to a research letter recently published in JAMA Oncology.
“Given the growth of withdrawals due to negative confirmatory trials and emerging evidence on the high spending associated with AA drugs, it is critical to balance early access against population-level exposure to cancer therapies with no benefit over standard of care,” Ravi Parikh, MD, MPP, of the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, and colleagues wrote in their study…
