Supplemental Biologics License Application submitted to FDA for avelumab for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma

Application is based on positive results from interim analysis of phase III JAVELIN Bladder 100 trial, which reported avelumab plus best supportive care (BSC) significantly extended survival of patients with disease that had not progressed on induction chemotherapy, vs. BSC alone

SPS commentary:

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody that is currently licensed as monotherapy for the treatment of metastatic Merkel cell carcinoma, and in combination with axitinib, for the first-line treatment of advanced renal cell carcinoma.


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