First Checkpoint Inhibitor for Previously Treated Patients with SCLC Approved by FDA


With this approval, nivolumab (Opdivo) offers a new treatment option for patients with small cell lung cancer whose cancer has progressed after 2 or more prior lines of therapy.

Officials with the FDA have approved nivolumab (Opdivo) as the first immuno-oncology treatment for previously treated patients with small cell lung cancer (SCLC), Bristol-Myers Squibb announced in a press release. Nivolumab is indicated for patients whose cancer has progressed after 2 or more prior lines of therapy.

“While immuno-oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer,” Leora Horn, MD, MSc, associate professor of medicine, Ingrame associate professor of cancer research, director of the thoracic oncology program and assistant vice chairman for faculty development at Vanderbilt University Medical Center, said in a press release. “Today’s approval of nivolumab is particularly exciting considering it is the first checkpoint inhibitor approved for these specific patients, and now we can finally treat this devastating disease from a different angle.”

This indication was granted under accelerated approval based on data from the SCLC cohort of the phase 1/2 CheckMate-032 trial evaluating nivolumab in patients who experienced disease progression after platinum-based chemotherapy. The trial included 245 patients with SCLC who had experienced disease progression after platinum-based chemotherapy and at least 1 prior therapy. Each of the patients received 3 mg/kg of nivolumab given by intravenous infusion over 60 minutes every 2 weeks and were included regardless of their PD-L1 status.

According to the data, 12% of the 109 previously treated patients receiving nivolumab responded to treatment, regardless of PD-L1 expression. Twelve patients experienced a partial response and 1 patient had a complete response. Among the patients who responded to treatment, the median duration of response was 17.9 months.

Ten percent of patients discontinued nivolumab and 1 dose was withheld in 25% of patients due to an adverse reaction, according to the study.

The most common adverse effects associated with nivolumab reported in at least 20% of patients were fatigue, decreased appetite, musculoskletal pain, dyspnea, nausea, diarrhea, constipation, and cough.

“Small cell lung cancer can be a very challenging disease, particularly for those who have already been through multiple types of treatment, as most patients relapse within a year of diagnosis,” Andrea Ferris, president and chairman of LUNGevity Foundation, said in a statement. “This approval marks a major milestone for the patients touched by this unrelenting disease and may motivate them to pursue further treatment where there previously were no other approved options.”


U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer [news release]. Bristol-Myers Squibb’s website. Accessed August 17, 2018.

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