The US Food and Drug Administration has approved Bristol-Myers Squibb's immunotherapy Opdivo as a treatment for the most common form of bladder cancer.
Physicians can now prescribe Opdivo (nivolumab) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The indication was cleared under accelerated approval based on tumour response rate and duration of response. Full approval may be contingent upon verification and description of clinical benefit in confirmatory trials, the firm noted.
The application primarily included data from CheckMate-275, a Phase II, open-label, single-arm study assessing the safety and efficacy of Opdivo in patients with the condition, in which 9.6 percent of patients responded to treatment with the drug, with 2.6 percent experiencing a complete response and 17 percent a partial response.
"Most people don't know how common bladder cancer is and that it is the fifth most diagnosed cancer. That's why we are dedicated to raising awareness and supporting research efforts that may offer more treatment options to patients who need them," said Stephanie Chisolm, director of Education and Research at Bladder Cancer Advocacy Network.
"This approval is another exciting step forward for the bladder cancer community and provides needed hope to patients and their families."
Opdivo is a PD-1 immune checkpoint inhibitor, already approved in the US for 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.