The FDA has given accelerated approval to Tecentriq (atezolizumab) injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Indications: Tecentriq is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma 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 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks. Dilute prior to intravenous infusion.

Efficacy and safety: Approval was based on a multicenter, single-arm trial in 310 patients with locally advanced or metastatic urothelial carcinoma. All patients received an IV infusion of atezolizumab, 1,200 mg every 3 weeks. Objective response rate was nearly 15%.

Side effects/risks: Most common adverse reactions include fatigue, decreased appetite, nausea, urinary tract infection, pyrexia, and constipation.

Citation: Atezolizumab for urothelial carcinoma [news release]. Silver Spring, MD: FDA Web Site. May 18, 2016. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm501878.htm. Accessed May 20, 2016.

Tecentriq [package insert]. South San Francisco, CA: Genentech, Inc 2016. http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761034s000lbl.pdf. Accessed May 20, 2016.