Understanding accelerated approval

Accelerated approval will be considered when approval "can be reliably based on evidence of the drug's effect on a surrogate endpoint that reasonably suggests clinical benefit or on evidence of the drug's effect on a clinical endpoint other than survival or irreversible morbidity, pending completion of studies to establish and define the degree of clinical benefits to patients."

- Federal Register, Dec. 11, 1992

Last week's recommendations by the FDA's Oncologic Drugs Advisory Committee (ODAC) highlight the flexibility the agency has in granting accelerated approval, a status that is intended to allow it to license products for sale based on convincing but not definitive evidence of efficacy.

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