Loading
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.
Shares Orphan drug designation, BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
Shares Full (traditional, regular) approval, BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.
Shares Full (traditional, regular) approval, Trial lifecycle: from protocol to label, Accelerated approval.
Shares NCCN Compendium and drug compendia, Companion diagnostic.
Shares Full (traditional, regular) approval, Accelerated approval.
Shares Orphan drug designation, BLA / NDA / MAA (marketing applications) and PDUFA dates.
Shares BLA / NDA / MAA (marketing applications) and PDUFA dates, Accelerated approval.