OnCo
termsTerm

Label, indication and label expansion

aka 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

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.

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.

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Trials & regulation

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Accelerated approvalBLA / NDA / MAA (marketing applications) and PDUFA datesCompanion diagnosticFull (traditional, regular) approvalNCCN Compendium and drug compendiaOrphan drug designation