Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years

A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints rather than the agency's accelerated pathway.

The authors argue that the limited use of accelerated approval may slow patient access to potentially life-saving therapies and suggest that regulators and sponsors reassess criteria for its application.

In unrelated regulatory news, the FDA released its user-fee rates for fiscal year 2027 covering prescription, generic, biosimilar, device and OTC drug programs, reflecting projected application volumes.