The company 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 submission was backed by data from CheckMate -275, a phase 2, single-arm clinical trial assessing the safety and efficacy of Opdivo in 270 patients with metastatic or unresectable urothelial carcinoma that has progressed or recurred after treatment with a platinum-based agent in the metastatic setting or within one year after neoadjuvant/adjuvant platinum therapy.
The trial's primary endpoint was confirmed objective response rate depending on assessments by the blinded independent review committee.
Progression-free survival (PFS), overall survival (OS), safety and quality of life were key secondary endpoints.
Bristol-Myers Squibb Melanoma and Genitourinary Cancers development lead Vicki Goodmansaid: “We look forward to working with regulatory authorities to potentially bring Opdivo to this patient community, which has historically had limited treatment options.”
The FDA action date is scheduled for 2 March 2017. In June, the regulator granted Opdivo with the breakthrough therapy designation for mUC.
A programmed death-1 (PD-1) immune checkpoint inhibitor, Opdivo was designed to utilize the body’s own immune system in restoring anti-tumor immune response.
As of now, Opdivo clinical development program is said to have enrolled over 25,000 patients.