The US Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) for BAVENCIO (avelumab) to treat a type of bladder cancer.

The US regulatory approval indicated BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody, co-developed and co-commercialised by Pfizer and EMD Serono, the biopharmaceutical business of Merck Pfizer.

Merck Biopharma business president Rehan Verjee said: “With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer.

“Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice.”

BAVENCIO is a first-line maintenance treatment for UC patients on chemotherapy

The FDA approval is supported by the results from the Phase 3 JAVELIN Bladder 100 trial, which showed improvement in overall survival (OS) with BAVENCIO as first-line maintenance plus best supportive care (BSC), than BSC alone.

BAVENCIO is intended for first-line maintenance treatment until disease progression or unacceptable toxicity, for patients that do not progress on platinum-containing chemotherapy.

The drug has been previously approved by the FDA in 2017, under the accelerated approval programme, for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy.

FDA has converted the accelerated approval to full approval, based on clinical benefit demonstrated in JAVELIN Bladder 100, a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study.

In March, EMD Serono and Pfizer decided to terminate the Phase III JAVELIN Head and Neck 100 study as it it established that avelumab (Bavencio) in addition to chemoradiotherapy (CRT) is unlikely to deliver the desired result.