EMD Serono has received Food and Drug Administration approval of BAVENCIO (avelumab) as a treatment for locally advanced or metastatic urothelial carcinoma (UC).
"This approval for BAVENCIO in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers," Merck KGaA EVA and Global Head of Research and Development Dr. Luciano Rossetti said. "Coming just a few weeks after the approval for metastatic Merkel cell carcinoma, we continue to demonstrate our ability to accelerate access to innovative medicines for patients in need."
Bladder cancer is the sixth-most common cancer in the U.S. It makes up approximately 90 percent of UC and when metastasized the prognosis is poor. Advanced UC has a high recurrence rate, and overall the five-year survival rate is approximately 5 percent.
"This approval builds on the ongoing clinical development program for BAVENCIO in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers," Pfizer Oncology Global President Liz Barrett said. "By drawing on the strength of the alliance, as well as Pfizer's deep experience in genitourinary cancers, we believe BAVENCIO will be an important treatment option, and we hope it will help to improve outcomes for these patients."
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