FDA Approves Opdivo for Advanced, Metastatic Bladder Cancer

Bristol-Myers Squibb Company recently announced that the FDA approved Opdivo (nivolumab) injection for patients with advanced or metastatic urothelial carcinoma.

The intravenous injection is for use in patients whose disease progressed during or after treatment with platinum-containing chemotherapy.

“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 US 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.”

This approval was accelerated due to beneficial tumor response rate and duration observed in a phase 3 clinical trial. However, this indication may be contingent upon findings from confirmatory trials, according to Bristol-Myers Squibb.

The recommended dose is 240-mg administered over 1 hour every 2 weeks until progression or toxicity is experienced, as confirmed by clinical trials.

Included in the CheckMate-275 clinical trial were 270 patients with advanced or metastatic urothelial carcinoma. The primary endpoint was confirmed objective response rate.

The investigators found that 19.6% of patients responded to treatment with Opdivo, with 2.6% experiencing a complete response, and 17% experiencing a partial response. The median duration of response was 10.3 months, and time to response was 1.9 months, according to the press release.

“As an oncologist, a nearly twenty-percent response rate in advanced and metastatic bladder cancer is extremely encouraging and clinically meaningful in this patient population,” said Jonathan E. Rosenberg, MD, Memorial Sloan Kettering Cancer Center.

The FDA previously granted Opdivo injection breakthrough therapy designation due to overwhelmingly positive findings.

In the study, 54% of patients experienced serious adverse events, including urinary tract infection, sepsis, diarrhea, small intestine obstruction, and health deterioration. Common adverse events were fatigue, musculoskeletal pain, nausea, and decreased appetite.

Risks associated with Opdivo include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, renal dysfunction, skin reactions, encephalitis, infusion reactions, and embryo-fetal toxicities, according to the press release.

Approximately 17% of patients discontinued treatment due to adverse events, and 4 treatment-related deaths occurred during the trial as a result of pneumonitis or heart failure, according to Bristol-Myers Squibb.

The Opdivo clinical development plan has been studied extensively in trials of various cancers, and has enrolled more than 25,000 patients.

“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.”