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FDA Approves Opdivo for Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of patients with small cell lung cancer (SCLC) who have not experienced success after at least two other treatments.

Opdivo is an immunotherapy that targets the PD-1 receptor and PD-L1 and PD-L2. Opdivo is also approved to treat patients with metastatic non-small cell lung cancer (NSCLC) that progressed after chemotherapy and at least one other treatment.

Progress for SCLC

This approval is a groundbreaking step forward for the SCLC community, in that, it’s the first new treatment development in nearly two decades. Most of the developments in lung cancer immunotherapy have been for NSCLC. Before now, there have been no approved immunotherapies for SCLC, which is a rare and fast-growing subtype of lung cancer. This approval marks a turn in the treatment approach for SCLC.

“While Immuno-Oncology innovations have dramatically changed how oncologists approach certain cancers, we have had limited progress for patients with small cell lung cancer,” said Leora Horn, M.D., M.Sc. “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.” 1

What does the research say?

The approval of Opdivo follows positive results from the Phase I/II CheckMate-032 trial which looked at the effectiveness of Opdivo as a treatment for patients whose disease progressed after platinum-based chemotherapy. This trial compared the use of Opdivo with the combined use of Opdivo and Yervoy (ipilimumab) for patients with metastatic tumors.

Of the 109 SCLC patients who received Opdivo, 12% (13 patients) responded positively to the treatment, regardless of their PD-L1 expression. 11% (12 patients) experienced a partial response and 1% (1 patient) had a complete response. The median duration of response was 17.9 months.

Serious side effects were reported in 2% of patients which included pneumonia, dyspnea, pneumonitis, pleural effusion and dehydration. More commonly experienced side effects were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%) and cough (20%).1

  1. U.S. FDA Approves Opdivo (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated SCLC. Bristol-Myers Squibb Press Release. Available at: