Bristol-Myers Squibb’s lead PD-1 inhibitor Opdivo has received approval from the US Food and Drug Administration for the treatment of bladder cancer.
Opdivo (nivolumab) – a drug that reveals cancer cells to the immune system – can now be used in the US to treat previously treated locally advanced or metastatic urothelial carcinoma, the most common form of bladder cancer.
The FDA’s approval was based on results from the Checkmate-275 trial in which Opdivo demonstrated an objective response rate of 19.6% in a population of 270 patients. In addition, 17% of patients had a partial response and 2.6% of patients had a complete response.
Among those that responded to Opdivo treatment, the median duration of response was 10.3 months.
“As an oncologist, a nearly twenty-percent response rate in advanced and metastatic bladder cancer is extremely encouraging and clinically meaningful in this patient population,” said Dr Jonathan Rosenberg of the Memorial Sloan Kettering Cancer Center.
BMS’ application for Opdivo use in bladder cancer was granted priority review by the FDA having previously been grated Breakthrough Therapy Designation in the same setting.
This new indication is under accelerated approval based on tumour response rate and duration of response, meaning a continued approval for this indication may be possible upon results from confirmatory trials.
Receiving FDA approval in bladder cancer now brings Opdivo’s approval tally up to six tumour types in just over two years. Although a considerable number, Opdivo has been struggling as of late thanks to its biggest rival in the market – MSD’s Keytruda – receiving approvals in other indications.
Most recently, Keytruda received European approval as a first-line treatment for metastatic non-small cell lung cancer – a setting BMS decided against pursuing after disappointing results from its Checkmate-026 phase 3 trial.