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Progression-free survival (PFS)

Oncologyยท appears in 400+ cited findings in this library

What it is and how the reviews use it

Progression-free survival (PFS) is an endpoint used in regulatory review documents to measure the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. It is a common metric in clinical trials to assess the efficacy of new therapies.

In the reviews, PFS is frequently used to evaluate the effectiveness of various treatments. For instance, the median PFS for placebo was 5.82 months in the Cstone โ€” Cejemly EMA EPAR public assessment report. For patients receiving gefitinib, the Median CNS PFS by ICR was 8.25 months, as noted in the SFL โ€” Aumseqa EMA EPAR public assessment report. Another example shows a median PFS of 3.0 months for Astellas Pharma Inc. โ€” Padcev in its FDA Review.

Real examples โ€” cited to the source page

Cstone โ€” CejemlyMedian PFS (months) for placebo5.82 monthsCstone โ€” Cejemly EMA EPAR public assessment report, p.92
Cheplapharm โ€” TarcevaPFS Hazard Ratio for squamous patients0.53Cheplapharm โ€” Tarceva EMA EPAR variation assessment report, p.17
SFL โ€” AumseqaMedian CNS PFS by ICR (gefitinib)8.25 monthsSFL โ€” Aumseqa EMA EPAR public assessment report, p.169
Amgen Inc. โ€” LumakrasMedian (95% CI) real-world PFS (months) for KRAS G12C-mutated NSCLC (Third Line)3.1 (2.4, 4.3) monthsAmgen Inc. โ€” Lumakras FDA Review, p.33
AstraZeneca PLC โ€” Calquencemedian PFS (months)22.6 monthsAstraZeneca PLC โ€” Calquence EMA EPAR public assessment report, p.78
Merck & Co., Inc. โ€” Weliregmedian PFS5.6 monthsMerck & Co., Inc. โ€” Welireg FDA Review, p.116
Astellas Pharma Inc. โ€” PadcevMedian Progression-Free Survival (PFS)3.0 monthsAstellas Pharma Inc. โ€” Padcev FDA Review, p.25
AbbVie Inc. โ€” VenclextaPFS events (VENCLEXTA + Obinutuzumab)29AbbVie Inc. โ€” Venclexta FDA Review, p.44

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

Explore the full evidence

Every Progression-free 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.

Progression-free survival (PFS) โ€” Explained with Cited FDA & EMA Examples | BioPharmaPT Oncology