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FDA grants priority review to avelumab for urothelial carcinoma
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The FDA granted priority review to avelumab for the treatment of locally advanced or metastatic urothelial carcinoma that progressed on or after platinum-based therapy, according to the drug’s manufacturers.
Avelumab (MSB0010718C; EMD Serono, Pfizer) is an investigational fully human anti–PD-L1 IgG1 monoclonal antibody.
The international clinical development program of avelumab includes at least 30 clinical programs, with nine phase 3 trials and more than 4,000 patients evaluated across more than 15 tumor types. The phase 3 JAVELIN Bladder 100 study, currently enrolling patients, is designed to evaluate avelumab in the first-line setting as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma.
“Advanced urothelial carcinoma remains a difficult-to-treat tumor, which is why we are developing a comprehensive clinical development program that involves phase 1 and 3 trials designed to address this challenge,” Chris Boshoff, MD, PhD, senior vice president and head of immuno-oncology, early development and translational oncology at Pfizer Global Product Development, said in a press release.
“We're continuing to accelerate our urothelial carcinoma development program and look forward to continuing our dialogue with the FDA.”
In November, the FDA granted priority review to avelumab for the treatment of metastatic Merkel cell carcinoma.
“Taken together with last year's filing for metastatic Merkel cell carcinoma, this biologics license application acceptance confirms our rapid and continued progress in the clinical development of avelumab,” Luciano Rossetti, MD, executive vice president and global head of research and development at the biopharma business of Merck KGaA, parent company of EMD Serono, said in the press release. “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.”
The FDA is expected to make a decision on avelumab by Aug. 27.