Immunotherapy approved for advanced urothelial Ca

The FDA has approved nivolumab (Opdivo) injection for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Also see: Urology FDA approvals of 2016

Bristol-Myers Squibb said that the approval covers treatment of patients 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.

“Urologists are familiar with Opdivo as it was approved in 2015 for advanced renal cell carcinoma. The drug has indications in at least four other cancers including melanoma, lung cancer, head and neck cancers, and Hodgkin’s lymphoma,” Leonard G. Gomella, MD, of Jefferson Sidney Kimmel Cancer Center, Thomas Jefferson University, told Urology Times. “Other checkpoint inhibitors have also demonstrated utility in advanced urothelial carcinoma trials and are very likely to follow in this disease state.”

Nivolumab is the second in class of immune checkpoint inhibitors approved for advanced bladder cancer. Tecentriq (atezolizumab) was the first PD-L1 checkpoint inhibitor approved by the FDA (in May 2016) for advanced urothelial carcinoma.

The nivolumab approval came following positive results from CheckMate-275, a phase II, open-label, single-arm, multicenter study evaluating 270 patients with advanced or metastatic urothelial carcinoma. In that study, 19.6% of patients responded to treatment with nivolumab, consisting of 2.6% of patients with a complete response and 17% of patients with a partial response. Among responders, the median duration of response was 10.3 months and the median time to response was 1.9 months.

The recommended dose for mUC is 240 mg, administered as an intravenous infusion over an hour every 2 weeks until disease progression or unacceptable toxicity.

Next: FDA approval accelerated thanks to strong beneficial tumor response rate and duration observed in phase III clinical trial

The FDA approval was accelerated thanks to a strong beneficial tumor response rate and duration observed in a phase III clinical trial.

Read - Uro Pipeline: FDA accepts biologics license application for bladder Ca agent

Dr. Gomella noted that the current approvals for checkpoint inhibitors in bladder cancer are specific for situations such as advanced urothelial carcinoma that failed platinum-based chemotherapy or worsening of disease in certain time frames in the setting of neoadjuvant or adjuvant chemotherapy.

“These immune checkpoint inhibitors are having tremendous responses across a spectrum of cancers beyond the GU system,” he said. “At the present time, these agents are primarily administered by medical oncologists and can cause unique immune-mediated side effects such as pneumonitis, colitis, nephritis, and others that can be challenging to manage.”

Bristol-Myers Squibb reported that the new indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

“Most people don’t know how common bladder cancer is and that it is the fifth most diagnosed cancer,” Stephanie Chisolm, of Bladder Cancer Advocacy Network, said in a Bristol-Myers Squibb press release. “That’s why we are dedicated to raising awareness and supporting research efforts that may offer more treatment options to patients who need them. This approval is another exciting step forward for the bladder cancer community and provides needed hope to patients and their families.”

Dr. Gomella is a consultant or adviser for Astellas, Janssen, MDxHealth, Merck Pharmaceuticals, and Bayer.

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