The Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for avelumab (EMD Serono and Pfizer) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy.
Avelumab is currently under investigation in the JAVELIN program, an international clinical development program including nine Phase 3 trials for at least 15 oncology indications. In December 2015, the companies initiated the JAVELIN Bladder 100 study, a Phase 3 trial evaluating avelumab as a first-line maintenance treatment for locally advanced or metastatic UC. Enrollment for this trial is currently ongoing.
A Prescription Drug User Fee Act (PDUFA) target action date of August 27, 2017 was set by the FDA for avelumab in this indication.
Avelumab is an investigational, fully human monoclonal IgG1 antibody against programmed death-ligand 1 (anti-PD-L1).