Edward Cliff, MD, Shares Updated Analysis of Accelerated Approval Drugs in Oncology

Dr. Cliff, of Harvard Medical School and Brigham and Women’s Hospital, spoke with Blood Cancers Today to describe an analysis of agents that were approved via the US Food and Drug Administration (FDA) Accelerated Approval Program over the last 10 years. The findings were presented live at the American Association for Cancer Research Annual Meeting 2024.

He noted that Accelerated Approval was initially implemented for treatments for HIV; however, it is now used primarily in oncology research. More than 80% of recent Accelerated Approval designations have been in oncology.

“We took a look at the last 10 years of the program and its use in oncology,” Dr. Cliff explained. “First, we wanted to know how many oncology drugs that are approved with Accelerated Approval go on to show true clinical benefit in clinical trials. The second part of our analysis looked at when the FDA converted those drugs from Accelerated Approval to full or regular approval and what the basis was for that decision.”

According to Dr. Cliff, 22% of agents that received Accelerated Approval were subsequently withdrawn from the market after they failed to show a clinical benefit in confirmatory trials. Furthermore, about 15% of drugs reached five years in the Accelerated Approval Program without being converted to full approval, “which means that their confirmatory trials have yet to give us an answer about whether they showed clinical benefit,” Dr. Cliff said.

The remaining 60% of drugs had been converted, Dr. Cliff reported, “but of those converted drugs, there was a proportion that had actually not shown a benefit in either overall survival or quality of life. That means a majority of Accelerated Approval drugs have not yet shown a benefit in the clinical outcome.”

Overall, Dr. Cliff stated that the objective of the analysis was not to categorize “good” and “bad” drugs, but to establish certainty of clinical benefit in oncologic therapies.