FDA Accepts Supplemental Biologics License Application for Nivolumab for Third-Line Small Cell Lung Cancer Treatment

The FDA has granted priority review to the application for the treatment of patients with small cell lung cancer whose disease has progressed after 2 or more prior lines of therapy.

Officials with the FDA have accepted Bristol-Myers Squibb’s supplemental biologics license application for nivolumab (Opdivo) in previously treated patients with small cell lung cancer (SCLC), according to a press release.

The agency has also granted priority review to the application and set an estimated action date for August 6, 2018.

The submission was based on safety and efficacy data from the phase 1/2 CheckMate -032 trial evaluating nivolumab monotherapy following platinum-based chemotherapy. In the trial, nivolumab monotherapy or nivolumab plus ipilimumab (Yervoy) were evaluated in advanced or metastatic solid tumors, including small cell lung cancer. Patients were treated until disease progression or unacceptable toxicity, and the trial included both PD-L1 expressors and non-expressors.

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According to the press release, nivolumab is a programmed death-1 immune checkpoint inhibitor designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response.

For patients with SCLC, symptoms are often not detected until the cancer is at an advanced stage and prognosis is poor. From the time of diagnosis, 5-year survival rates for limited stage SCLC are 10% to 13%, and for extensive stage, survival rates are less than 2%.

Nivolumab is currently approved in the United States for the treatment of patients with melanoma, non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma, urothelial carcinoma, colorectal cancer, and hepatocellular carcinoma.

“We are pleased with this important step forward in the FDA’s consideration to expand the use of Opdivo to patients with small lung cancer who have received 2 or more lives of previous treatment,” Sabina Maier, development lead, thoracic cancers, from Bristol Myers Squibb, said in the press release.


US Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Patients with Small Cell Lung Cancer and Grants Priority Review [news release]. Bristol-Myers Squibb’s website. https://news.bms.com/press-release/bristolmyers/us-food-and-drug-administration-accepts-supplemental-biologics-license-ap. Accessed April 19, 2018.