FDA Approves Bavencio for Advanced Bladder Cancer

The FDA has granted approval to avelumab (Bavencio, Pfizer) injection for treatment of patients with locally advanced or metastatic urothelial carcinoma (UC). The drug is indicated for those who have disease progression during or following platinum-containing therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing therapy

The FDA previously granted accelerated approval to Bavencio for the treatment of metastatic Merkel cell carcinoma in adult and pediatric patients 12 years and older.

In a phase 1, open-label, single-arm, multicenter study, Bavencio demonstrated efficacy and safety for the treatment of 242 patients with locally advanced or metastatic UC.

Bavencio is designed to prevent tumor cells from using programmed death ligand (PD-L1) antibody as protection against white blood cells, and therefore exposing them to anti-tumor responses. It has also been shown to induce antibody-dependent cell-mediated cytotoxicity in vitro.

The most common adverse effects reported include fatigue, infusion-related reaction, muscoskeletal pain, nausea, decreased appetite/hypophagia, and urinary tract infection.

Reference

FDA grants Bavencio (avelumab) approval for a common type of advanced bladder [news release]. Pfizer’s website. http://www.pfizer.com/news/press-release/press-release-detail/fda_grants_bavencio_avelumab_approval_for_a_common_type_of_advanced_bladder_cancer. Accessed May 10, 2017.