FDA Approves New Option for Urothelial Carcinoma

The FDA has approved Bavencio (avelumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

The approval was based on the results of an open-label, single arm, multi-center study of 242 patients who received 10 mg/kg intravenous avelumab every 2 weeks until radiographic or clinical progression or until unacceptable toxicity. Patients were given pre-medication with an antihistamine and acetaminophen prior to each administration.
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FDA Approves New Option for Urothelial Carcinoma
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Overall response rates in patients followed for at least 13 weeks was 13.3% and 16.1% in those followed for a least 6 months. Median time to response was 2 months.

Deaths related to adverse reactions occurred in 6% of patients, and serious adverse reactions were reported in 41% of patients. The most frequent serious reactions included urinary tract infection, abdominal pain, muscle pain, renal failure, and dehydration.  The most common adverse reactions included fatigue, nausea, decreased appetite, and urinary tract infection.

—Michael Potts

Reference:

FDA grants accelerated approval to avelumab for urothelial carcinoma [press release]. FDA. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm.