Opdivo® (nivolumab) Approved for Treatment of Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for the treatment of metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1

About Small Cell Lung Cancer

According to the American Cancer Society, more than 234,000 people will be diagnosed with lung cancer and 154,050 will die from the disease in 2018, making it the leading cause of cancer death. SCLC primarily is associated with smoking and accounts for about 10 to 15 percent of all lung cancers. In the United States, about 27,000 individuals with SCLC will be diagnosed in 2018.  The survival for most SCLC patients is less than a year and there have been no recent advances in its treatment.2-5

About Opdivo

Opdivo is a precision cancer medicine that belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 may enhance the ability of the immune system to fight cancer. Opdivo works by blocking PD-1. PD-1 inhibitors are being investigated in more than 30 different cancers, and it is already approved for the treatment of melanoma and lung cancer and researchers continue to evaluate its effectiveness in different types of cancer.

The approval of Opdivo was based on data provided to the FDA from the ongoing CheckMate -032 study evaluating Opdivo in patients who experienced disease progression after platinum-based chemotherapy.1 Twelve percent of SCLC patients treated with Opdivo after platinum-based chemotherapy responded to treatment and among these responders, the average duration of response was 1 and a half years.1


  1. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-firs
  2. National Cancer Institute. Small Cell Lung Cancer Treatment. Lung Cancer. https://www.cancer.gov/types/lung/hp/small-cell-lung-treatment-pdq. Updated April 20, 2018. Accessed May 30, 2018.
  3. American Cancer Society. Key Statistics About Small Cell Lung Cancer. https://www.cancer.org/cancer/small-cell-lung-cancer/about/key-statistics.html. Revised January 4, 2018. Accessed May 30, 2018.
  4. Decision Resources Group Epidemiology Data. Burlington, MA: Decision Resources Group.
  5. American Cancer Society. Small Cell Lung Cancer Survival Rates, by Stage. https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 30, 2018.

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