Opdivo Gains FDA Approval for Common Bladder Cancer

Bristol-Myers Squibb’s prized immuno-oncology drug gained another label expansion.

The Food and Drug Administration (FDA) announced on Thursday it approved Opdivo for treating patients with urothelial carcinoma, which is the most common form of bladder cancer.

It can be prescribed for patients diagnosed with the locally advanced or metastatic form of the condition that experience disease progression during or following platinum-containing chemotherapy or have 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, in the official announcement.

“This approval is another exciting step forward for the bladder cancer community and provides needed hope to patients and their families,” continued Chisolm.

The FDA granted this indication after reviewing tumor response rate and duration of response from a Phase 2 open-label study exploring the safety and efficacy of the drug for 270 individuals diagnosed with this disease.

Results from the study revealed 19.6 percent of patients responded to treatment with Opdivo with 2.6 percent of the volunteers experiencing a complete response followed by 17 percent undergoing a partial response.

Opdivo is a PD-1 immune checkpoint inhibitor that uses the body’s own immune system to fight cancer, according to Reuters.

The drug previously gained regulatory approval to treat advanced melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, recurrent or metastatic squamous cell carcinoma of the head and neck, along with Hodgkin lymphoma.