# Full (traditional, regular) approval

Source: https://onco.cc/terms/full-approval/  
OnCo record `full-approval` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: full approval; traditional approval; regular approval; standard approval; converted to full approval; conversion to regular approval; full FDA approval; received full approval; gained full approval; regular FDA approval

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/New_Drug_Application
- Wikipedia: https://en.wikipedia.org/wiki/New_Drug_Application

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [BLA / NDA / MAA (marketing applications) and PDUFA dates](https://onco.cc/terms/bla-nda/), [Cancer Drugs Fund (England)](https://onco.cc/terms/cancer-drugs-fund/), [Conditional marketing authorisation (EU)](https://onco.cc/terms/conditional-approval/), [Confirmatory trial](https://onco.cc/terms/confirmatory-trial/), [FDORA 2022 accelerated approval reforms](https://onco.cc/terms/fdora-2022/), [Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments](https://onco.cc/terms/fdca/), [Indication withdrawal](https://onco.cc/terms/approval-withdrawal/), [Japan conditional early approval and time-limited approval](https://onco.cc/terms/japan-conditional-early-approval/), [Label, indication and label expansion](https://onco.cc/terms/label-indication/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)

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JSON: https://onco.cc/api/v1/entities/full-approval.json