FDA accepts BLA for avelumab for the treatment of metastatic urothelial carcinoma for Priority Revie

Second Biologics License Application accepted by the FDA for avelumab.

Merck and Pfizer have announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for avelumab, as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. The BLA was submitted by EMD Serono, the biopharmaceutical business of Merck in the US and Canada. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 27 August 2017, for avelumab in this indication.

"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 Luciano Rossetti, Executive Vice President, Global Head of R&D 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% of urothelial cancers and is the sixth most common cancer in the US.

"Advanced urothelial carcinoma remains a difficult-to-treat tumour, which is why we are developing a comprehensive clinical development program that involves Phase I and III trials designed to address this challenge," said 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 an investigational, fully human anti-PD-L1 antibody. The FDA’s Priority Review status reduces the review time from 10 months to a goal of six months from the day of filing acceptance and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. In November 2016, the FDA accepted, and granted Priority Review status to, the BLA for avelumab for the treatment of patients with metastatic Merkel cell carcinoma.

The international clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs, including nine Phase III trials, and more than 4,000 patients evaluated across more than 15 tumour types. In December 2015, Merck and Pfizer announced the initiation of a Phase III study (JAVELIN Bladder 100) of avelumab in the first-line setting as a maintenance treatment in patients with locally advanced or metastatic UC. This trial is currently enrolling patients.