An Easier Path To Accelerated Approval For Cancer

The FDA established the Accelerated Approval Program in 1992 to expedite approvals for drugs that treat dangerous conditions and “fill unmet medical needs.”¹ The program allows sponsors to prove efficacy using a surrogate endpoint in a Phase I or Phase II clinical trial and then later perform a post market confirmatory study to confirm the connection between the surrogate endpoint and the expected clinical benefit, verifying the drug’s efficacy.

In July of 2022, NPR reviewed FDA records of drugs that received accelerated approval (AA) and found that of the AA drugs with incomplete confirmatory studies, 42% of them took more than one year to begin the confirmatory study or hadn’t begun the study at all. Of that 42%, 19 were more than three years past AA and four were more than 10 years past.² In other words, a significant number of drugs with AA were used for years — sometimes more than a decade — without confirmation of their efficacy.