The U.S. Food and Drug Administration (FDA) announced on Wednesday, Mar. 4, the approval of Opdivo (nivolumab) as treatment for patients suffering from metastatic squamous non-small cell lung cancer (NSCLC) that has progressed after or while on platinum-based chemotherapy.
The cancer drug marketed by Bristol-Myers Squibb was reviewed as NSCLC treatment under the priority review program of the FDA, which expedites assessments for drugs designed for treating serious conditions to provide dramatic improvement in the effectiveness or safety of treating serious conditions. Opdivo received approval over three months ahead of the deadline the FDA set for completing its review of the drug.
"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 Office of Hematology and Oncology at the FDA Center for Drug Evaluation and Research.
He added that Opdivo's approval provides doctors and patients with information abut the drug's survival advantages, which may influence lung cancer trials and general patient care in the future.
"We're thankful to the many patients and healthcare providers that partnered with us to develop a new treatment that has the potential to address [an] unmet need," said Lamberto Andreotti, Bristol-Myers Squibb chief executive director.
As a cancer drug, Opdivo was designed to block the protein PD-1 in cells blocking the natural ability of the body to fight off cancerous cells. It was proven effective in a randomized trial involving 272 subjects, 135 of which were given Opdivo. The other 137 were administered docetaxel. Those on Opdivo outlived those on doxetaxel by up to 3.2 months more.
Another clinical trial was carried out to test for efficacy and safety in Opdivo, a single-arm trial involving 117 patients who underwent progression after getting at least one systemic regimen alongside platinum-based chemotherapy. It was designed to measure the percentage of patients who experience complete disappearance or partial shrinkage of lung cancer tumors or objective response rate, and it showed that 15 percent of participating patients exhibited ORR. Out of that number, 59 percent established ORR for at least six months.
In the United States, lung cancer accounts for the most number of cancer-related deaths, claiming 159,260 lives in 2014. In the same year, it was estimated that 224,210 new cases will be diagnosed. NSCLC is the most common type of the cancer, affecting seven out of eight patients.
