FDA Approves Opdivo (Nivolumab) for Small Cell Lung Cancer

The US Food and Drug Administration had approved the immunotherapy drug Opdivo (nivolumab) to treat people with small cell lung cancer (SCLC). This is the first immunotherapy drug approval for SCLC. It’s for people with SCLC that has metastasized (spread to other parts of the body) and has continued to get worse after being treated with at least 2 types of therapy including chemotherapy.

Opdivo is already on the market to treat some other types of cancer, including some cases of non-small cell lung cancer, melanoma skin cancer, liver cancer, and Hodgkin lymphoma. Opdivo works by blocking a protein called PD-1 on certain immune cells. This protein helps cancer cells avoid being found and destroyed by the body’s immune system. Blocking the PD-1 protein can help the immune system recognize the cancer cells and attack them.

The new approval is based on a clinical trial of 109 people with advanced SCLC whose cancer got worse after prior treatment. The trial measured overall response rate, which is the percentage of participants whose tumors got smaller. The overall response rate of the trial was 12% (13 patients). The duration of response, which is the amount of time the improvement lasted, was 6 months or longer in 10 of the patients.

The FDA granted the approval under its priority review program, one way the FDA tries to speed up approval of drugs to treat serious diseases.

The most common side effects of Opdivo are fatigue, shortness of breath, joint or muscle pain, decreased appetite, cough, nausea, diarrhea, and constipation. Serious side effects can include pneumonia, fluid build-up in the lungs, and dehydration.

Less common but more serious side effects can occur if the immune system attacks healthy tissues in the body, such as the lungs, colon, liver, kidneys, or hormone-producing glands.

Opdivo is marketed by Bristol-Myers Squibb.