FDA approves additional indication for Opdivo

March 4, 2015

FDA has expanded the approved use of nivolumab (Opdivo, Bristol Myers Squibb) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

FDA has expanded the approved use of nivolumab (Opdivo, Bristol-Myers Squibb) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Related:New treatment for advanced melanoma approved by FDA

According to the American Lung Association, lung cancer is the leading cancer killer in both men and women in the United States. In 1987, it surpassed breast cancer to become the leading cause of cancer deaths in women Lung cancer causes more deaths than the next three most common cancers combined (colon, breast and pancreatic). An estimated 158,040 Americans are expected to die from lung cancer in 2015, accounting for approximately 27% of all cancer deaths.

“FDA’s approval of Opdivo adds to the arsenal of drugs that are currently available to treat patients with advanced [metastatic] squamous non-small cell lung cancer. This affords patients with a new treatment options and potential increase In time to survival,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy.

Opdivo’s efficacy to treat squamous NSCLC was established in a randomized trial of 272 participants, of whom 135 received Opdivo and 137 received docetaxel. The trial was designed to measure the amount of time participants lived after starting treatment (overall survival). On average, participants who received Opdivo lived 3.2 months longer than those participants who received docetaxel.

Safety and efficacy of Opdivo to treat squamous NSCLC was supported by a single-arm trial of 117 participants who had progressed after receiving a platinum-based therapy and at least 1 additional systemic regimen. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 15% of participants experienced ORR, of whom 59% had response durations of six months or longer.

Fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea and constipation are the most common side effects of Opdivo. The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands.

Opdivo for squamous NSCLC was reviewed under FDA’s priority review program. Opdivo is being approved more than 3 months ahead of the prescription drug user fee goal date of June 22, 2015, the date when the agency was scheduled to complete its review of the application.

FDA previously approved Opdivo to treat patients with unresectable (cannot be removed by surgery) or metastatic melanoma who no longer respond to other drugs.