Bavencio (avelumab)
- Region
- 🇪🇺 EU
- Active substance
- avelumab
- Company
- Merck Europe B.V.
- Status
- Authorised
- Therapeutic area
- Neuroendocrine Tumors
- CHMP opinion
- Thu 20 Jul 2017
- EU approval
- Mon 18 Sep 2017
- Application
- EMEA/H/C/004338
- ATC
- L01FF04
- Official record
- www.ema.europa.eu
Indication
Bavencio is indicated as monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC). Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). 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.
Regulatory milestones
No milestones recorded in the last year.
Follow Bavencio
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.