Bristol Meyer Squibb Companyannounced that the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of Opdivo to patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) that has progressed on or after platinum-containing therapy. The FDA granted the application priority review and previously granted Opdivo Breakthrough Therapy Designation for mUC in June 2016, reinforcing the need for new treatment approaches in this patient population. The FDA action date is March 2, 2017.
“We are pleased that the FDA has accepted our application for Opdivo in previously treated patients with metastatic urothelial carcinoma, an advanced form of bladder cancer,” said Vicki Goodman, M.D., development lead, Melanoma and Genitourinary Cancers, Bristol-Myers Squibb. “We look forward to working with regulatory authorities to potentially bring Opdivo to this patient community, which has historically had limited treatment options.”
The submission was based on data from CheckMate -275, a Phase 2, single-arm clinical trial evaluating the safety and efficacy of Opdivo in 270 patients with metastatic or unresectable urothelial carcinoma that has progressed or recurred following treatment with a platinum-based agent in the metastatic setting or within one year after neoadjuvant/adjuvant platinum therapy. The primary endpoint in the trial was confirmed objective response rate (ORR) based on assessments by the blinded independent review committee. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), safety and quality of life. Data from this study was recently presented at the 2016 European Society for Medical Oncology Congress.
