Clinical Edge

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Bavencio Approved for Urothelial Carcinoma

FDA news release; 2017 May 9

The FDA granted accelerated approval to Bavencio (avelumab) for patients with locally advanced or metastatic urothelial carcinoma (UC).

Indications: Bavencio is a programmed death ligand-1-blocking antibody indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression:

  • During or following platinum-containing chemotherapy.
  • Within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Dosage and administration: Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks.

Efficacy and safety: Approval is based on data from an open-label, single arm, multi-center study showing that patients receiving Bavencio had an overall response rate of ~13% at 13 weeks and ~16% at 6 months. Median time to response was 2 months.

Side effects/risks: The most common adverse reactions are fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.


FDA grants accelerated approval to avelumab for urothelial carcinoma. [news release]. Silver Spring, MD: FDA May 9, 2017. Accessed May 14, 2017.

Bavencio [package insert]. Rockland, MA: EMD Serono, Inc. 2017. Accessed May 14, 2017.