Hazard ratio
Oncology· appears in 400+ cited findings in this library
What it is and how the reviews use it
Hazard ratio (HR) is a statistical measure used in clinical trials to compare the survival or event-free survival rates between two groups, such as a treatment group and a control group. It quantifies the relative risk of an event (e.g., disease progression, death) occurring in one group compared to another over a specified period. In the context of regulatory reviews, it serves as a key endpoint to evaluate the efficacy of new treatments.
Across the regulatory documents, Hazard ratio is frequently used to assess various outcomes, including progression-free survival (PFS) and overall survival (OS). For instance, the FDA review for PFIZER's Ibrance reported a Hazard Ratio (HR) for PFS of 0.58. Similarly, the EMA EPAR for Ipsen S.A.'s Cometriq noted an OS Hazard Ratio (interim OS analysis) of 0.98. The FDA Summary Review for UNITED THERAP's Unituxin also presented an EFS Hazard Ratio of 0.57, indicating its application across different event-free survival measures.
Real examples — cited to the source page
| PFIZER — Ibrance | Hazard Ratio (HR) for PFS | 0.58 | FDA Review (NDA/BLA 207103, 2019), p.90 |
| Ipsen S.A. — Cometriq | OS Hazard Ratio (interim OS analysis) | 0.98 | EMA EPAR public assessment report (EMEA/H/C/0026, p.57 |
| UNITED THERAP — Unituxin | EFS Hazard Ratio | 0.57 | FDA Summary Review (NDA/BLA 125516, 2015), p.4 |
| Novartis AG — Tabrecta | Overall survival hazard ratio for METex14 in NSCLC | 1.82 | EMA EPAR public assessment report (EMEA/H/C/004, p.10 |
| JANSSEN BIOTECH — Zytiga | overall survival hazard ratio | 0.79 | FDA Review (NDA/BLA 202379, 2016), p.249 |
| BRISTOL MYERS SQUIBB — Empliciti | PFS Hazard Ratio | 0.70 | FDA Summary Review (NDA/BLA 761035, 2, p.12 |
| Servier — Onivyde pegylated liposomal (previously Onivyde) | hazard ratio for Arm A vs Arm B | 0.67 | EMA EPAR pu, p.56 |
| Sanofi — Jevtana | PSA progression-free hazard ratio | 0.75 | EMA EPAR public assessment report (EMEA/H/C/002018, 2, p.47 |
Different drugs were studied in different trials — these values are not head-to-head comparisons.
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Figures are as stated in the cited source documents. Educational reference only — not medical or investment advice.