Sorafenib
Sorafenib (Nexavar, Bayer AG) has 3 EU-approved indications in 3 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hepatocellular carcinoma1 | |||
None | Monotherapy | Any line | None |
| Renal cell carcinoma1 | |||
None | Monotherapy | Any line advanced | Failed prior interferon-alpha or interleukin-2 based therapy, or considered unsuitable for such therapy |
| Thyroid cancer1 | |||
None | Monotherapy | Any line advanced | Differentiated thyroid cancer only; Progressive; refractory to radioactive iodine |
Full text of section 4.1 (therapeutic indications)
Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Label history
44 changes to the Nexavar label since 2007, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes