The FDA ( Food and Drug Administration ) has expanded the approved use of Opdivo ( Nivolumab ) to treat patients with advanced ( metastatic ) squamous non-small cell lung cancer ( NSCLC ) with progression on or after Platinum-based chemotherapy.
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 ( Taxotere ).
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.
The 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 one 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.
The most common side effects of Opdivo are fatigue, shortness of breath, musculoskeletal pain, decreased appetite, cough, nausea and constipation.
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 the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition.
Opdivo is being approved more than three 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.
The FDA previously approved Opdivo to treat patients with unresectable or metastatic melanoma who no longer respond to other drugs.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. ( Xagena )
Source: FDA, 2015