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FDA Approves Avelumab for Advanced or Metastatic Urothelial Carcinoma

On June 30, 2020, the FDA approved avelumab (Bavencio, Merck/Pfizer) for the first-line maintenance treatment of patients with locally advanced metastatic or urothelial carcinoma who have not progressed on first-line platinum-containing chemotherapy.

This approval is based on results from the phase 3 JAVELIN Bladder 100 Trial, which enrolled  700 patients with locally advanced or metastatic urothelial carcinoma. Patients were randomized in a 1:1 ratio to avelumab plus best supportive care or best supportive care alone.

The study demonstrated a significant improvement in overall survival (OS) with avelumab plus best supportive care (21.4 months) versus best supportive care alone (14.3 months). This improvement in OS represents a 31% reduction in the risk of death in the overall study population. 

The most common adverse events associated with avelumab include fatigue, infused-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.—Alexis Hyams

Source: Pfizer. FDA approves BAVENCIO as First-Line Maintenance Treatment for patients with Locally Advanced or Metastatic Urothelial Carcinoma. June 30, 2020. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-bavencio-first-line-maintenance-treatment. Accessed July 1, 2020.

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