FDA grants breakthrough therapy designation to Bavencio for urothelial carcinoma maintenance
Click Here to Manage Email Alerts
The FDA granted breakthrough therapy designation to avelumab for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma.
The agency will review the supplemental biologics license application through its real-time oncology review pilot program.
The FDA based the breakthrough therapy designation on results of an interim analysis of the randomized phase 3 JAVELIN Bladder 100 trial, which included 700 patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy.
Researchers randomly assigned patients to best supportive care with or without first-line maintenance therapy with avelumab (Bavencio; EMD Serono, Pfizer), a human anti-PD-L1 antibody.
OS served as the primary endpoint. Secondary endpoints included PFS, antitumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes.
As Healio previously reported, results of an interim analysis showed a statistically significant improvement in OS with avelumab among all patients, as well as those with PD-L1-positive tumors. Avelumab exhibited a safety profile consistent with prior studies.
“Bavencio is the first immunotherapy to demonstrate a statistically significant improvement in overall survival in a phase 3 clinical trial in the first-line setting for patients with locally advanced or metastatic urothelial carcinoma,” Chris Boshoff, MD, PhD, chief development officer for oncology at Pfizer Global Product Development, said in a company-issued 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.”
The FDA approved avelumab in 2017 for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or who experienced disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.