Urothelial Carcinoma Treatment Receives FDA Breakthrough Therapy Designation
The U.S. Food and Drug Administration granted breakthrough therapy designation to avelumab (Bavencio) for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma.
The designation was based on positive results from an interim analysis of the Phase III JAVELIN Bladder 100 trial of patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy who received avelumab in combination with best supportive care as a first-line maintenance treatment compared with patients treated with best supportive care only.
“Bavencio is the first immunotherapy to demonstrate a statistically significant improvement in overall survival in a Phase III clinical trial in the first-line setting for patients with locally advanced or metastatic urothelial carcinoma,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology, Pfizer Global Product Development in a press release. “Participation in the Real-Time Oncology Review program, coupled with the Breakthrough Therapy Designation, reflect the potential impact of BAVENCIO in this patient setting and provide the opportunity to work towards bringing this treatment option to patients as quickly as possible.”
Read the full press release here.