FDA Approves Bavencio as Frontline Maintenance Therapy in Advanced Bladder Cancer

The Food and Drug Administration (FDA) approved Bavencio (avelumab) as first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy, according to EMD Serono, the agent’s manufacturer.

This is the first and only FDA-approved immunotherapy to induce a significant survival benefit in the frontline setting, according to Dr. Petros Grivas.

“As the first immunotherapy to demonstrate a statistically significant improvement in overall survival in the first-line setting in locally advanced or metastatic urothelial carcinoma, the FDA approval of avelumab is one of the most significant advances in the treatment paradigm in this setting in 30 years,” he said in a press release.

The supplemental biologics license application that was approved was based on results from the phase 3 JAVELIN Bladder 100 study — designed to evaluate Bavencio plus plus best supportive care, compared with best supportive care alone.

The trial showed that frontline maintenance treatment with Bavencio demonstrated 7.1-month improvement in median overall survival, compared with best supportive care alone (21.4 months versus 14.3 months). Moreover, this resulted in a 31% reduction in the risk for death in the overall population.

“With median overall survival of more than 21 months measured from randomization, the longest overall survival in a phase III trial in advanced urothelial carcinoma, the JAVELIN Bladder 100 regimen with avelumab as a first-line switch maintenance treatment has the potential to become a new standard of care based on its proven ability to reinforce the benefit (response or stable disease) of induction chemotherapy and extend the lives of patients with this devastating disease,” said Grivas, one of the principal investigators in the JAVELIN Bladder 100 trial.

The priority review for Baencio was completed under the FDA’s Real-Time Oncology Review pilot program, after the agent received breakthrough therapy designation.

“Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer,” Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network, said in the release. “We wholeheartedly support the development of new and promising treatments like BAVENCIO that can offer patients and their loved ones hope.”

Check back later on what you need to know about this approval.