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. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm. Accessed May 14, 2017.
Bavencio [package insert]. Rockland, MA: EMD Serono, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf. Accessed May 14, 2017.