The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024.
The FDA accepted 2 supplemental biologics applications (sBLA) for nivolumab (Opdivo; Bristol Myers Squibb)-based regimens as treatment of resectable stage 2A to 3B non-small cell lung cancer (NSCLC), according to a press release. The applications were submitted based on positive survival and response outcomes observed during the CheckMate -77T trial, which evaluated nivolumab with chemotherapy followed by surgery and adjuvant nivolumab as perioperative treatment for resectable NSCLC.
Lung cancer is the primary cause of cancer-related deaths around the world. Most lung cancer diagnoses are NSCLC (84%), and approximately 60% of patients with NSCLC have resectable disease. Nevertheless, more than half of patients are expected to recur after surgery, which often leads to death.
"Between 30% to 55% of non-small cell lung cancer patients who undergo surgery will experience disease recurrence,” said Abderrahim Oukessou, MD, vice president, thoracic cancers global program lead, BMS, in the press release. “We are working to expand options that improve outcomes for patients with resectable disease, as part of our comprehensive approach to the treatment of multiple types of cancer, including and especially in earlier stages.”
Immunotherapy is a cancer treatment that can boost survival outcomes in the neoadjuvant and adjuvant setting. Nivolumab is a type of immunotherapy called a PD-1 immune checkpoint inhibitor (ICI), which optimizes a person’s immune system to fight cancer. In 2014, it became the first PD-1 ICI to be approved for the treatment of cancer.
The CheckMate-77T is a phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating 2 nivolumab regimens— neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
Nivolumab-based combinations improved event-free survival, meeting the primary end point. In addition, nivolumab benefitted secondary end points of pathologic complete response and major pathologic response. Overall survival is also a secondary end point, but data continue to be collected. Further, there were no new safety signals observed with perioperative nivolumab.
Nivolumab is currently indicated as a single and combination-based therapy for certain patients with metastatic NSCLC and unresectable malignant pleural mesothelioma. It has largely shown effectiveness for lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma as a neoadjuvant and adjuvant agent.
The most common adverse reactions associated with nivolumab across various clinical trials include fatigue, musculoskeletal pain, rash, pruritus, gastrointestinal upset (diarrhea, nausea, vomiting, decreased appetite), cough, upper respiratory tract infection, and headache. Both nivolumab regimens showed consistent safety signals with previous studies.
Data from the CheckMate-77T were presented at the European Society of Medical Oncology (ESMO) Congress 2023. Following this most recent application approval, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 8, 2024.
“The acceptance of these applications underscores our impactful progress in addressing unmet needs across several NSCLC treatment settings and brings us one step closer to offering a new perioperative [Nivolumab]-based regimen to patients who may benefit," Oukessou concluded in the press release.
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Opdivo in Resectable Non-Small Cell Lung Cancer. BMS. News Release. February 7, 2024. Accessed on February 7, 2024. https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Announces-Acceptance-of-U.S.-and-EU-Regulatory-Filings-for-Neoadjuvant-Opdivo-nivolumab-and-Chemotherapy-Followed-by-Surgery-and-Adjuvant-Opdivo-in-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx