medwireNews: The PD-L1 inhibitor avelumab has been approved by the US FDA as a maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed on first-line platinum chemotherapy.
The decision is based on findings of the JAVELIN Bladder 100 trial which demonstrated a significant overall survival gain for patients given maintenance avelumab every 2 weeks, beginning up to 10 weeks after completing chemotherapy, versus best supportive care.
The recommended intravenous avelumab dose of 800 mg delivered over 60 minutes every 2 weeks is associated with adverse events including fatigue, musculoskeletal pain, urinary tract infection, and rash.
Avelumab has previously been approved for the treatment of urothelial carcinoma that has progressed after platinum-based chemotherapy, as well as other indications including advanced renal cell carcinoma in combination with axitinib, Merkel cell carcinoma, and lung cancer.
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