The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s Opdivo injection (nivolumab) for intravenous use in previously treated, locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer.
This indication is approved based on tumour response rate and duration of response and its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
In the CheckMate -275 Phase II, open-label, single-arm, multicentre trial, Opdivo demonstrated an objective response rate of 19.6%, while the percentage of patients with a complete response was 2.6%.
The percentage of patients with a partial response was 17%.
Bristol-Myers Squibb US Commercial president Chris Boerner said: “Our goal to help more patients is further realised in today’s approval for Opdivo in this population and we are excited that our Immuno-Oncology therapy is now an option and potential hope for these patients.
“This is evidence of our commitment to Immuno-Oncology and to bringing therapies, like Opdivo, to more and more patients in need of additional choices.”
The company received the application priority review and breakthrough therapy designation for Opdivo from the FDA to treat patients with locally advanced or mUC.
Beginning in the cells that line the inside of the bladder, the cancer is the fifth most commonly diagnosed in the US, with an estimated 77,000 new diagnoses last year leading to more than 16,000 deaths.
The majority of these cancers are diagnosed at an early stage, but rates of recurrence and progression are high. About 50% to 70% of patients are expected to experience a recurrence within five years.