The FDA announced today that it has expanded the indication of Bristol-Myers Squibb's anticancer medication nivolumab (Opdivo) to include the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
The FDA announced today that it has expanded the indication of Bristol-Myers Squibb’s anticancer medication nivolumab (Opdivo) to include the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Opdivo, a PD-1 inhibitor, was initially approved in December 2014 for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Last week, the FDA granted Priority Review designation to the Biologics Licensing Application (BLA) that sought the expanded indication, setting a goal date for a decision of June 22, 2015.
The agency based its recent nod on several trials examining the safety and efficacy of Opdivo in treating squamous NSCLC. In one study, patients treated with Opdivo were found to live an average of 3.2 months longer than those who received docetaxel, while in a second trial, 15% of Opdivo-treated participants who had progressed after receiving a platinum-based therapy and at least one additional systemic regimen experienced partial tumor shrinkage or complete disappearance.
“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,” said Richard Pazdur, M.D., director of the FDA’s Office of Hematology and Oncology Products, in a press release. “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.”
The most common adverse events experienced by Opdivo-treated patients include fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea and constipation. The drug’s use is also associated with severe immune-mediated side effects in otherwise healthy organs such as the lung, colon, liver, kidneys and hormone-producing glands.
NSCLC is the most common form of lung cancer, affecting 7 out of 8 lung cancer patients, according to an FDA press release. In 2014, it was estimated that there were 224,210 new lung cancer diagnoses and 159,260 lung cancer related deaths.