US regulators have awarded Bristol-Myers Squibb's immunotherapy Opdivo its sixth breakthrough therapy status, this time for its potential in treating bladder cancer.
The firm is developing Opdivo (nivolumab) to target unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
Bladder cancer is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year; urothelial carcinoma is the most common type, accounting for around 90 percent of cases.
"Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence and remains an area where new treatment approaches are needed, further underscoring the importance of this designation for Opdivo," said Jean Viallet, global clinical research lead, Oncology, at BMS.
BMS said it is expecting to file a marketing application for the bladder cancer indication in the US, based on data from the Phase II CA209-275 study, in the "coming months".
The drug is already on the market to treat certain patients with melanoma, non-small cell lung cancer, renal cell carcinoma and classical Hodgkin lymphoma, and is being assessed in various different tumour types.