Posted from: Monday, September 17, 2018 - 12:18 PM - Present

Opdivo Receives Small Cell Lung Cancer Indication

August 17, 2018 – The U.S. FDA has approved a new indication for Opdivo® (nivolumab), manufactured by Bristol-Myers Squib, to treat patients whose metastatic small cell lung cancer (SCLC) has progressed following platinum-based chemotherapy and at least one other line of therapy.

In a clinical trial, patients who received Opdivo and responded to treatment had a median duration of response (DOR) of 17.9 months. However, of patients who participated in the trial, only 12% had a partial or complete response. Serious adverse events occurred in 45% of patients who participated in the trial.

Small cell lung cancer is an aggressive, hard-to-treat cancer that makes up as much as 15% of lung cancer diagnoses. In the United States, approximately 27,000 new cases are expected to be diagnosed in 2018. Opdivo’s new indication makes the drug the first in the PD-1/PD-L1 class to be approved to treat SCLC. Recommended dosing under the new indication is 240 milligrams given by intravenous (IV) infusion every two weeks until disease progression or treatment intolerance.

First FDA approved in 2014, Opdivo now has almost a dozen approved indications to treat various cancers.

Last Updated Friday, October 19, 2018 - 01:31 AM.