FDA Accepts Bristol Myers Squibb’s Biologics License Application for Opdivo’s Subcutaneous Formulation Across All Previous Indications

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Bristol Myers Squibb (BMS) announced that the FDA has accepted its Biologics License Application (BLA) for a subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20). According to the company, the application was accepted across all previously approved adult, solid tumor Opdivo indications, including monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, and in combination with chemotherapy or cabozantinib. The FDA assigned the application with a Prescription Drug User Fee Act date of February 28, 2025.

BMS reported that the filing and acceptance of the BLA were supported by data collected from the Phase III CheckMate -67T study, in which subcutaneous nivolumab demonstrated noninferiority to intravenous (IV) Opdivo in time-averaged Opdivo serum concentration over 28 days and trough serum concentration at steady state. Additionally, the oral formulation’s safety profile was found to be consistent with the IV formulation.¹

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, PhD, VP, global program lead, BMS, in a press release. “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in three-to-five minutes rather than a 30-to-60-minute infusion.”

Among its multiple indications, Opdivo received FDA approval in combination with chemotherapy as a neoadjuvant treatment for particular patients with resectable non-small cell lung cancer (NSCLS). For this indication, the approval was based on results from the CheckMate -816 trial, which was the first positive Phase III trial of an immunotherapy-based combination used before surgery for resectable NSCLC, according to BMS. Overall, the results demonstrated a 37% reduction in the risk of disease progression, recurrence, or death compared to solo chemotherapy.²

“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 Mark Awad, MD, PhD, CheckMate -816 study investigator, clinical director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, in a 2022 press release. “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery. Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers.”

Opdivo first received an accelerated approval in 2014 as an injection for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600-mutation positive, a BRAF inhibitor.³

References

1. U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase). BMS. May 6, 2024. Accessed May 6, 2024. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

2. U.S. Food and Drug Administration Approves Opdivo® (nivolumab) with Chemotherapy as Neoadjuvant Treatment for Certain Adult Patients with Resectable Non-Small Cell Lung Cancer. BMS. March 4, 2022. Accessed May 6, 2024. https://news.bms.com/news/details/2022/U.S.-Food-and-Drug-Administration-Approves-Opdivo-nivolumab-with-Chemotherapy-as-Neoadjuvant-Treatment-for-Certain-Adult-Patients-with-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx

3. Bristol-Myers Squibb Receives Accelerated Approval of Opdivo (nivolumab) from the U.S. Food and Drug Administration. BMS. December 22, 2014. Accessed May 6, 2024. https://news.bms.com/news/details/2014/Bristol-Myers-Squibb-Receives-Accelerated-Approval-of-Opdivo-nivolumab-from-the-US-Food-and-Drug-Administration/default.aspx