FDA accepts for priority review Bristol-Myers’ sBLA for Opdivo for urothelial carcinoma use

The US Food and Drug Administration (FDA) has accepted for priority review Bristol-Myers Squibb’s supplemental biologics license application (sBLA) for Opdivo (nivolumab) in previously treated patients With advanced form of bladder cancer.

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.