PRINCETON, N.J.—Bristol-Myers Squibb Co. has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo injection for intravenous use for the treatment of 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.

 

Opdivo has now been approved in six tumor types in just over two years.

 

This new indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

The recommended dose for mUC is 240 mg administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity. In the CheckMate -275 trial, 19.6 percent of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 2.6 percent and the percentage of patients with a partial response was 17 percent. Among responders, the median duration of response was 10.3 months. The median time to response was 1.9 months.

 

“Our goal to help more patients is further realized 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,” said Chris Boerner, president of U.S. Commercial, Bristol-Myers Squibb. “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 FDA granted the application priority review and previously granted Breakthrough Therapy Designation to Opdivo for the treatment of patients with locally advanced or 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.

 

“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.”