FDA Approves First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

The U.S. Food and Drug Administration (FDA) recently approved BAVENCIO®(avelumab) for the maintenance treatment of patients with locally advanced or metastatic bladder cancer that has not progressed with first-line platinum-containing chemotherapy.

The drug approval is based on results from the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with BAVENCIO as first-line maintenance plus best supportive care (BSC) compared with BSC alone.

“The results from JAVELIN Bladder 100, presented at the ASCO 2020 Virtual Scientific Meeting, are practice changing for us to maintain the responses that chemotherapy provides for metastatic urothelial cancer,” said Tian Zhang, MD, MHS, assistant professor of Medicine at Duke Cancer Institute. “This is one of the first studies since chemotherapy to extend overall survival for patients with metastatic urothelial cancer. At Duke, we will be integrating avelumab into our practice immediately after completing chemotherapy, rather than waiting until disease recurrence. By adapting clinical trial results early into our practice, we improve access to life-prolonging treatments for our patients.”

In 2017, the FDA approved BAVENCIO under the accelerated approval program for the treatment of patients with locally advanced or metastatic bladder cancer who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval.