Stivarga(regorafenib)
Oncology· 2227 cited findings· 3 source documents
Company: Bayer Aktiengesellschaft →
What the regulatory reviews say
Stivarga (regorafenib) is a drug reviewed under NDA/BLA 203085. In a randomized, double-blind, placebo-controlled, multicenter phase III study (Study 15982), 760 patients were randomized. The Overall Survival (OS) for Stivarga was 10.6 months, compared to 7.8 months for placebo, with an Overall Survival Hazard Ratio of 0.63 (p-value <0.0001). Progression-free Survival (PFS) (mRECIST) for Stivarga was 3.1 months, versus 1.5 months for placebo. The PFS Hazard Ratio (RECIST) was 0.43 (95% CI: 0.35, 0.52).
Notable safety findings include regorafenib discontinuations due to adverse events in 10% of patients. Haemoglobin decreased in 78.5% of patients (All Grades), with 4.7% experiencing Grade 3 and 0.6% experiencing Grade 4. The incidence of Grade 3 hypertension was 18% in patients >= 65 years and 9% in younger patients. There was 1 Grade 4 hypertension event in patients >= 65 years and 0 in younger patients.
Regulatory approval for Stivarga was granted on April 27, 2017, following an Accelerated Assessment procedure agreed on April 19, 2012.
Key figures — cited to the source page
| Overall Survival (STIVARGA) | 10.6 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.30 |
| Overall Survival (Placebo) | 7.8 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.30 |
| Overall Survival Hazard Ratio | 0.63 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.30 |
| Progression-free Survival (mRECIST) (STIVARGA) | 3.1 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.30 |
| Progression-free Survival (mRECIST) (Placebo) | 1.5 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.30 |
| regorafenib discontinuations due to adverse events | 10 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.57 |
| Haemoglobin decreased (All Grades) | 78.5 | Bayer Aktiengesellschaft — Stivarga EMA EPAR public assessme, p.72 |
| Approval Date | April 27, 2017 | BAYER HLTHCARE — Stivarga FDA Review (NDA/BLA 203085, 2019), p.1 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.