A major development for patients with urothelial carcinoma with Merck and Pfizer announcing they have submitted avelumab to the FDA.
It has priority review status by the FDA, which could reduce the review time to six months, having already been granted priority review status for the treatment of patients with metastatic Merkel cell carcinoma.
The new submission seeks approval for avelumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) with disease progression on or after platinum-based therapy.
The company was unable to confirm the timing of any submissions in Australia.
“Taken together with last year’s filing for metastatic Merkel cell carcinoma, this BLA acceptance confirms our rapid and continued progress in the clinical development of avelumab,” said Dr Luciano Rossetti, Executive Vice President, Global Head of Research and Development at the biopharma business of Merck. “We continue to evaluate avelumab in cancers that have limited or suboptimal treatment choices, such as metastatic or locally advanced urothelial carcinoma, to hopefully be able to provide patients with new treatment options for fighting their disease.”
Despite advances in the treatment of UC, the prognosis for patients remains poor, particularly when the disease has metastasized. Bladder cancer makes up approximately 90 per cent of urothelial cancers and is one of the most common cancers.
“Advanced urothelial carcinoma remains a difficult-to-treat tumor, which is why we are developing a comprehensive clinical development program that involves Phase I and III trials designed to address this challenge,” said Dr Chris Boshoff, Senior Vice President and Head of Immuno-oncology, Early Development and Translational Oncology, Pfizer Global Product Development.
“We’re continuing to accelerate our urothelial carcinoma development program and look forward to continuing our dialogue with the FDA.”
Avelumab is a fully human anti-PD-L1 antibody.
The companies said the clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs, including nine Phase 3 trials and more than 4,000 patients evaluated across more than 15 tumour types.