Avelumab
Avelumab (Bavencio, Merck Europe B.V.) has 3 EU-approved indications in 3 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Renal cell carcinoma1 | |||
None | + axitinib | 1L advanced | None |
| Urothelial carcinoma1 | |||
None | Monotherapy | Maint. advanced | Progression-free following platinum-based chemotherapy |
| Merkel cell carcinoma1 | |||
None | Monotherapy | Any line metastatic | None |
Full text of section 4.1 (therapeutic indications)
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).
Label history
25 changes to the Bavencio label since 2018, 2 of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes