FDA Approves Immunotherapy Drug for Locally Advanced or Metastatic Urothelial Carcinoma


Urothelial carcinoma accounts for approximately 90% of all bladder cancers and becomes increasingly challenging to treat as it spreads through the layers of the bladder wall.

The FDA has approved avelumab (Bavencio, Pfizer/Merck KGaA) as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

As the sixth most common cancer in the United States, more than a half-million new cases of bladder cancer were diagnosed in 2018, with approximately 200,000 deaths globally. Urothelial carcinoma accounts for approximately 90% of all bladder cancers and becomes increasingly challenging to treat as it spreads through the layers of the bladder wall.

“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,” said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network, in a statement. “We wholeheartedly support the development of new and promising treatments like Bavencio that can offer patients and their loved ones hope.”

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody that has been shown to engage both the adaptive and innate immune functions. Priority review of the drug was completed as part of the FDA’s Real-Time Oncology Review pilot program and was followed with a breakthrough therapy designation.

The FDA approval was based on results from the phase 3 Javelin Bladder 100 study, which found a significant 7.1-month improvement in median overall survival (OS) with avelumab as a first-line maintenance therapy combined with best supportive care. In the study, 700 patients were randomly assigned to receive either avelumab plus standard of care or standard of care alone.

In PD-L1-positive patients, investigators observed a 44% reduction in the risk of death among patients who received avelumab. In an exploratory analysis of patients with PD-L1-negative tumors, the OS hazard ratio was 0.85.

A fatal adverse event (AE) occurred in 1 patient, and serious AEs occurred in 28% of patients receiving avelumab. Those reactions included urinary tract infection, pain, acute kidney injury, hematuria, sepsis, and infusion-related reactions. The most common AEs included fatigue, musculoskeletal pain, urinary tract infection, and rash.

“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,” said Petros Grivas, MD, PhD, one of the principal investigators in the Javelin Bladder 100 trial, in a statement.


FDA Approves Bavencio as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma [news release]. EMD Serono; June 30, 2020. http://media.emdserono.com/2020-06-30-FDA-Approves-BAVENCIO-as-First-Line-Maintenance-Treatment-for-Patients-with-Locally-Advanced-or-Metastatic-Urothelial-Carcinoma. Accessed July 1, 2020.

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