The US Food and Drug Administration (FDA) approved avelumab for locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.1

The accelerated approval comes less than 2 months after avelumab, a human anti-PD-L1 IgG1 monoclonal antibody, was approved for Merkel cell carcinoma.

The open-label, single arm, multicenter JAVELIN study ( Identifier: NCT01772004) on which approval was based enrolled 242 patients. After premedication with an antihistamine and acetaminophen, patients received avelumab 10 mg/kg intravenously over 60 minutes every 2 weeks until radiographic /clinical progression or unacceptable toxicity.

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The indication is based on tumor response rate and duration of response. Overall response rate was 13.3% (95% CI 9.1-18.4) in the 30 patients followed for at least 13 weeks, and 16.1% (95% CI 10.8-22.8) in those followed for at least 6 months.

Median duration of response ranged from 1.4-plus to 17.4-plus months in these 2 groups but had not been reached in either group. Median time to response was 2.0 months.

Six percent of patients died due to an adverse reaction, and serious adverse reactions were reported in 41%.

The most common adverse reactions were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

RELATED: FDA Approves Durvalumab for Relapsed/Refractory Urothelial Carcinoma

Full prescribing information is available at: label/2017/761078s000lbl.pdf


  1. FDA grants accelerated approval to avelumab for urothelial carcinoma [news release]. Silver Spring, MD: US Food and Drug Administration; May 9, 2017. ApprovedDrugs/ucm557162.htm. Accessed May 9, 2017.