Nivolumab, produced by Bristol Myers Squibb under the brand name Opdivo, was approved for use in combination with platinum-doublet chemotherapy for adult patients with resectable NSCLC in the neoadjuvant setting, said the FDA, adding that this is their first approval for neoadjuvant therapy for NSCLC.
Neoadjuvant therapy is “treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery,” according to the National Cancer Institute. “Examples of neoadjuvant therapy include chemotherapy.” Platinum-doublet chemotherapy is known as “the cornerstone of standard chemotherapy as first-line treatment of advanced NSCLC.”
The use of Opdivo in chemotherapy “showed a statistically significant improvement in EFS (event-free survival) with a 37% reduction in the risk of progression, recurrence or death,” according to a press release from Bristol Myers Squibb.
A ‘turning point’ in treatment
“Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” said Dr. Mark Awad, study investigator of the successful Phase 3 clinical trial and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC.”