Bristol Myers Squibb’s Opdivo (nivolumab) has been approved by the US Food and Drug Administration to treat a subset of patients with urothelial carcinoma (UC), the most common type of bladder cancer.
The drug has been specifically authorised for use alongside cisplatin and gemcitabine as a first-line treatment for adults with unresectable or metastatic UC.
The FDA’s decision was supported by positive results from the late-stage CheckMate-901 trial, which evaluated the Opdivo combination followed by Opdivo monotherapy against cisplatin-gemcitabine alone in patients with previously untreated unresectable or metastatic UC.
With a median follow-up of 33 months, treatment with the Opdivo regimen reduced the risk of death by 22%, demonstrating a median overall survival of 21.7 months versus 18.9 months for cisplatin-gemcitabine alone.
Patients in the Opdivo cohort also had their risk of disease progression or death reduced by 28%, with a median progression-free survival of 7.9 months versus 7.6 months for the cisplatin-gemcitabine group.
More than 83,000 people are expected to be diagnosed with bladder cancer in the US this year, with UC accounting for approximately 90% of bladder cancer cases.
Up to 25% of patients present with metastatic disease and while the majority of UCs are diagnosed at an early stage, about half of patients who undergo radical surgery will experience disease progression and recurrence.
“This approval marks an important advancement in a historically difficult-to-treat setting where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,” said Guru Sonpavde of the AdventHealth Cancer Institute.
Opdivo is already approved in the US for the adjuvant treatment of adults with UC who are at high risk of recurrence after undergoing radical resection of UC, as well as to treat certain adults with locally advanced or metastatic UC who have experienced disease progression.
Commenting on the latest approval, Wendy Short Bartie, senior vice president and general manager, US haematology and oncology at BMS, said: “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”