FDA approves supplemental Biologics License Application for avelumab (Bavencio) as first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma

Approval for use in patients whose disease has not progressed with 1st line platinum-chemotherapy was based on phase 3 JAVELIN Bladder 100 study, which reported improvement in median overall survival with avelumab plus best supportive care (BSC) vs BSC alone (21.4 vs.14.3 months)

SPS commentary:

The European Medicines Agency recently validated for review a licence extension application for avelumab as first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma.

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