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Overall survival (OS)

Oncologyยท appears in 400+ cited findings in this library

What it is and how the reviews use it

Overall survival (OS) is a key endpoint used in FDA and EMA regulatory review documents to measure the length of time from a specific point (such as the start of treatment or diagnosis) until death from any cause. It is a critical measure of treatment efficacy in clinical trials, often serving as a primary or secondary endpoint.

In the reviewed documents, OS is frequently reported as a median duration in months, a percentage at a specific time point, or as a Hazard Ratio (HR). For instance, the ASTRAZENECA โ€” Faslodex FDA Review reported a median OS of 22.8 months, while the Bristol-Myers Squibb Company โ€” Sprycel EMA EPAR variation assessment report noted an Overall survival (OS) at 5 years after last dose of 79.4%. The ELI LILLY AND CO โ€” Lartruvo FDA Review presented an Overall Survival Hazard Ratio of 0.52.

Real examples โ€” cited to the source page

ASTRAZENECA โ€” Faslodexmedian OS (months)22.8Faslodex FDA Review, p.41
BAYER HLTHCARE โ€” StivargaOS Hazard Ratio0.63Stivarga FDA Review, p.190
Bristol-Myers Squibb Company โ€” SprycelOverall survival (OS) at 5 years after last dose79.4Sprycel EMA EPAR variation assessment r, p.11
Incyte Corporation โ€” MinjuviOS rate (%) at 12 months for placebo+R293.7Minjuvi EMA EPAR variation assessment report, p.68
Astellas Pharma Inc. โ€” XtandiHR for overall survival0.633Xtandi EMA EPAR public assessment report, p.66
Cstone โ€” CejemlyMedian OS (months) in sugemalimab+chemotherapy arm25.4Cejemly EMA EPAR public assessment report, p.91
Teva B V โ€” Trisenoxoverall survival (OS) at 3 years (standard arm)77Trisenox EMA EPAR variation assessment report, p.10
Merck & Co., Inc. โ€” Keytrudamedian overall survival (months)20.0Keytruda FDA Review, p.77

Different drugs were studied in different trials โ€” these values are not head-to-head comparisons.

Explore the full evidence

Every Overall finding in the library โ€” searchable and answerable in plain language โ€” is in the Oncology research library โ†’

Figures are as stated in the cited source documents. Educational reference only โ€” not medical or investment advice.

Overall survival (OS) โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Oncology