Regorafenib
Regorafenib (Stivarga, Bayer Pharma AG) has 3 EU-approved indications in 3 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Gastrointestinal stromal tumour1 | |||
None | Monotherapy | 3L+ advanced | Progressed on or are intolerant to prior treatment with imatinib and sunitinib |
| Colorectal cancer1 | |||
None | Monotherapy | Any line metastatic | Previously treated with, or are not considered candidates for, available therapies (including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy) |
| Hepatocellular carcinoma1 | |||
None | Monotherapy | 2L | Previously treated with sorafenib |
Full text of section 4.1 (therapeutic indications)
Stivarga is indicated as monotherapy for the treatment of adult patients with - metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1) - unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib - hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Label history
28 changes to the Stivarga label since 2014, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes