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The ordinary form of drug approval, granted when a trial has shown real clinical benefit such as longer survival, as opposed to an accelerated approval granted on an early stand-in measure and still awaiting confirmation.
Most oncology drugs first approved under accelerated approval later 'convert' to full approval when the confirmatory trial reads out positive (blinatumomab in 2018, tarlatamab in 2026 after DeLLphi-304); others go straight to full approval on a positive randomised phase 3. The distinction matters for payers and guidelines, and because a drug with accelerated approval may lose its indication if confirmation fails. Regulators may convert with a narrowed indication (ODAC concerns on dosing, as with belantamab's US label), and the phrase 'full approval' is often reported as a milestone in company and trial pages.
Shares FDORA 2022 accelerated approval reforms, Indication withdrawal, BLA / NDA / MAA (marketing applications) and PDUFA dates.
Shares FDORA 2022 accelerated approval reforms, Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments, BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
Shares Japan conditional early approval and time-limited approval, Conditional marketing authorisation (EU), Accelerated approval.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Confirmatory trial.
Shares Japan conditional early approval and time-limited approval, BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
Shares Label, indication and label expansion, BLA / NDA / MAA (marketing applications) and PDUFA dates, Confirmatory trial, Accelerated approval.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
Shares Japan conditional early approval and time-limited approval, Conditional marketing authorisation (EU), Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments, BLA / NDA / MAA (marketing applications) and PDUFA dates.