Bristol-Myers Squibb’s Opdivo Immunotherapy Receives FDA Approval for Bladder Cancer

Bristol-Myers Squibb’s immuno-oncology drug, Opdivo, has received US Food and Drug Administration (FDA) approval to treat patients with a common form of bladder cancer, known as urothelial carcinoma. The immunotherapy is approved for a number of other indications, including the treatment of metastatic melanoma, non-small cell lung cancer, and advanced renal cell carcinoma.

The expanded indication will specifically affect cancer patients with locally advanced or metastatic urothelial carcinoma who show disease progression despite treatment with platinum-containing chemotherapy. Patients with disease progression within one year of receiving neoadjuvant or adjuvant chemotherapy, will also be eligible to be treated using the injectable.

“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’s decision was made based on the results of a Phase II open-label clinical trial which involved 270 patients with urothelial carcinoma. The safety and efficacy study found that nearly 20 percent of patients responded to treatment with Opdivo.

While only 2.6 percent of patients experienced a complete response, the remaining 17 percent showed at least a partial response. Bristol-Myers Squibb reported that the median duration of response among responders was 10.3 months, with the median time to response coming in at 1.9 months.

“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.”

Bristol-Myer’s Squibb’s application for Opdivo in bladder cancer was granted priority review by the FDA. The approval is based upon both tumor response rate and duration of response, however it may be contingent upon confirmation of results in future clinical trials.