March 04, 2015
The U.S. Food and Drug Administration announced that it has approved a new indication for Bristol-Myers Squibb’s nivolumab (Opdivo).
The expanded use now includes treating patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression or after platinum-based chemotherapy.
“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”
Nivolumab is a PD-1 inhibitor. The drug’s efficacy was established in a trial of 272 participants (135 taking nivolumab and 137 taking docetaxel). Results showed that patients taking nivolumab lived 3.2 months longer than those on docetaxel.
Common side effects include: cough, nausea, constipation, shortness of breath, decreased appetite, fatigue, musculoskeletal pain. More severe side effects can be immune-mediated involving healthy organs (lung, colon, liver, kidneys, and hormone-producing glands).
Prior to this approval, nivolumab was approved to treat unresectable or metastatic melanoma in patients who do not respond to other drugs.
1. U.S. Food and Drug Administration. FDA expands approved use of Opdivo to treat lung cancer [press release]. www.fda.gov. 2015 Mar 4.