October 2, 2020

The U.S. FDA has approved a new indication for Opdivo® (nivolumab) used in combination with Yervoy® (ipilimumab) to provide first-line treatment of adults who have malignant pleural mesothelioma that cannot be removed by surgery (unresectable). Both medications are manufactured by Bristol Myers Squibb, and are the first FDA-approved immunotherapy for this indication.

An estimated 20,000 people in the United States are diagnosed with mesothelioma annually. The cancer, which affects the lining of the lungs, is caused by inhaling asbestos fibers. In most cases, patients have malignant pleural mesothelioma, meaning that fluid and cancer cells have accumulated between the chest wall and the lung. The disease is also usually inoperable at the time of diagnosis. The five-year survival rate for malignant pleural mesothelioma is 12%.

In a clinical study, Opdivo plus Yervoy produced a median survival time of 18.1 months compared to 14.1 months in patients who underwent chemotherapy. Opdivo’s recommended dosing under the new indication is 240mg administered via intravenous (IV) infusion over the course of 30 minutes every two weeks or 480mg every four weeks until disease progression or unacceptable toxicity occur. Yervoy’s recommended dosing under the new indication is 3mg/kg of body weight administered via 90-minute IV infusion once every three weeks for a maximum of four doses.

Opdivo first received FDA approval in 2014, while Yervoy received its initial FDA approval in 2011. Both are indicated to treat multiple forms of cancer and are often used together as a combination therapy.

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