Full (traditional, regular) approval
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.
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not linked directly; found by shared links- TermSurrogate endpoint
Shares Confirmatory trial, Accelerated approval.