Acceptance is based on CheckMate -816 trial results where the agency granted priority review status to the Bristol Myers Squibb drug and assigned a PDUFA goal date of July 13, 2022.
The FDA has accepted a supplemental biologic application for nivolumab (Opdivo, Bristol Myers Squibb) plus chemotherapy for the neoadjuvant treatment of individuals with resectable non–small cell lung cancer (NSCLC).
The acceptance is based on results from the CheckMate -816 trial where the FDA granted the application priority review status and assigned a Prescription Drug User Fee Act goal date of July 13, 2022.
“While significant progress has been made in how we treat NSCLC, there remains a strong need for new options that can prevent recurrence and improve clinical outcomes, especially when a patient’s cancer is caught in earlier stages,” Abderrahim Oukessou, MD, vice president of thoracic cancers development lead at Bristol Myers Squibb, said in a statement. “The FDA’s acceptance of our application marks an important step in our effort to offer patients and physicians the first immunotherapy-based option that can be given before surgery to extend the time patients can continue living without disease progression or recurrence.”.
CheckMate -816 was the first positive phase 3 trial with an immunotherapy-based combination in the neoadjuvant setting of NSCLC.
In the study, nivolumab with chemotherapy demonstrated clinically meaningful and statistically significant improvement in the pathologic complete response and event-free survival compared with chemotherapy alone and before surgery.
For the primary analysis, 358 individuals were randomized to receive either nivolumab 360 mg plus histology-based platinum doublet chemotherapy every 3 weeks for 3 doses or just platinum doublet chemotherapy every 3 weeks for 3 doses, each followed by surgery.
The secondary endpoints include major pathologic response, overall survival, and time to death or distant metastases.
The safety profile remained consistent with previously reported studies in NSCLC.
Investigators are exploring the use of immunotherapy in the adjuvant, neoadjuvant, and peri-operative settings, as well as in association with chemoradiation, in non-metastatic NSCLC.
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s immune system to restore anti-tumor immune response.
In July 2014, nivolumab was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world, and it is now approved in more than 65 countries.
Nivolumab has 20 FDA indication as both a single agent and in combination with other drugs. It is also indicated for multiple uses that include, but are not limited to, Hodgkin lymphoma, NSCLC, metastatic and unresectable melanoma, and renal cell carcinoma.
It is also indicated to be used as first-line treatment, as well as after a first-line treatment, depending on the disease state it is intended to treat and for which other drugs it is being combined.
Severe adverse events (AEs) include complications of allogenic hematopoietic stem cell transplantation, embryo-fetal toxicity, immune-mediated AEs, and infusion-related reactions.
Common AEs vary and depend on whether the drug is used in combination with which drug it is combined.
US Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) plus chemotherapy as neoadjuvant treatment for resectable non–small cell lung cancer. Bristol Myers Squibb. News release. February 28, 2022. March 1, 2022. https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-Plus-Chemotherapy-as-Neoadjuvant-Treatment-for-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx