May 26, 2020

The U.S. FDA has approved a new indication for Opdivo® (nivolumab) and Yervoy® (ipilimumab), both of which are manufactured by Bristol Myers Squibb, for use in combination with two cycles of platinum-doublet chemotherapy to provide first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC).

Lung cancer is the second most common cancer and the leading cause of cancer death in the United States. NSCLC is the most commonly diagnosed form of lung cancer, accounting for up 85% of cases. The prognosis for lung cancer patients is often poor. For patients who have metastatic NSCLC, in which the disease has spread beyond their lungs to other parts of the body, the five-year survival rate is just 6%.

In a clinical trial, Opdivo and Yervoy combined with two cycles of platinum-doublet chemotherapy delivered a median overall survival time of 14.1 months compared to 10.7 months with chemotherapy alone. At one year of follow up, 63% of patients who received Opdivo and Yervoy with two cycles of platinum-doublet chemotherapy were still alive, compared to 47% of patients treated with chemotherapy alone.

Recommended dosing under the new indication is Opdivo 360mg once every three weeks via 30-minute intravenous (IV) infusion and Yervoy 1mg/kg of patient’s body weight once every six weeks via 30-minute IV infusion. Treatment with Opdivo and Yervoy should continue until disease progression or unacceptable toxicity occur, or for up to two years in patients without disease progression. A black box warning cautions that Yervoy is associated with severe and fatal immune-mediated adverse reactions. These reactions typically occur during treatment but can occur weeks to months after discontinuation of Yervoy.

Opdivo first received FDA approval in 2014, while Yervoy received its initial FDA approval in 2011. Both drugs are indicated to treat multiple forms of cancer.

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