# Label, indication and label expansion

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

## TL;DR

A drug's label is the official document stating exactly which patients (the indication) it is approved for, at what dose, with what warnings. Each new cancer, line of therapy or combination added to it is a label expansion, approved through a supplemental application.

## Summary

Oncology drugs accumulate indications over years (pembrolizumab has more than 40), each backed by its own trial and reviewed as a supplemental BLA or NDA. The label wording (for example 'PD-L1 CPS ≥10', 'after at least two prior lines', 'in combination with chemotherapy') defines reimbursement and guideline placement, and restrictions can be tightened (dose, population) after new data. Off-label prescribing, guided by NCCN compendium listings, is legal and common, especially for rare cancers, but may not be reimbursed. Boxed warnings flag the most serious risks (ILD for T-DXd, CRS for T-cell engagers) and REMS programmes add access controls.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: label expansion; label expansions; indication; approved indication; new indication; expanded indication; expanded label; expanded approval; US label; FDA label; drug label; prescribing information; on-label; off-label; off-label use; sBLA; sNDA; supplemental BLA; supplemental NDA; supplemental approval; boxed warning; black box warning; label restriction; boxed warnings; label restrictions

## Sources

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

## 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/), [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Full (traditional, regular) approval](https://onco.cc/terms/full-approval/), [NCCN Compendium and drug compendia](https://onco.cc/terms/nccn-compendium/), [Orphan drug designation](https://onco.cc/terms/orphan-designation/), [Trial lifecycle: from protocol to label](https://onco.cc/terms/trial-lifecycle/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)

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