European Commission Approves Subcutaneous Opdivo for Various Tumors

Bristol Myers Squibb, headquartered in PRINCETON, N.J., announced a pivotal advancement in cancer treatment with the European Commission's approval of a novel formulation of Opdivo® (nivolumab). This new formulation introduces subcutaneous administration, a solution for injection, and a new strength of 600 mg/vial. Known as Opdivo SC, this version is co-formulated with recombinant human hyaluronidase (rHuPH20) and is approved for use across various adult solid tumors. It can be administered as a monotherapy or in combination with other treatments such as chemotherapy or cabozantinib.

The approval marks a significant milestone in immunotherapy, enabling a fast 3- to 5-minute injection compared to the traditional intravenous method. Dana Walker, M.D., M.S.C.E., the global program lead for Opdivo, highlighted its consistent efficacy and comparable safety to the intravenous version, noting its potential to revolutionize cancer care. The approval reflects Bristol Myers Squibb's commitment to enhancing patient experience by providing efficient and convenient treatment options.

The decision by the European Commission was informed by data from the CheckMate -67T clinical trial, which showed comparable pharmacokinetics and safety between Opdivo SC and its intravenous counterpart. The trial emphasized the noninferiority of key pharmacokinetic endpoints, demonstrating that Opdivo SC maintains similar efficacy. The trial included patients with advanced or metastatic clear cell renal cell carcinoma who had undergone limited prior systemic therapy. Results indicated a favorable objective response rate with Opdivo SC compared to intravenous Opdivo, reinforcing its potential as an effective treatment option.

The CheckMate -67T findings were shared at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium, among other prestigious gatherings, and were published in the Annals of Oncology. With Opdivo SC now approved in the European Union, patients have access to a streamlined treatment approach, offering the same benefits as the intravenous formulation with added convenience.

Laurence Albiges, M.D., Ph.D., a medical oncology professor and head of the Oncology Department at Gustave Roussy, emphasized the transformative nature of subcutaneous nivolumab in cancer treatment. This approach allows for personalized treatment plans, improving both patient experience and healthcare resource management. The European Commission's approval is valid across all EU member states, as well as Iceland, Liechtenstein, and Norway.

In the United States, subcutaneous nivolumab was approved by the FDA on December 27, 2024, under the brand name Opdivo QvantigTM. Bristol Myers Squibb acknowledges the contributions of patients and researchers involved in the CheckMate -67T trial, highlighting the collaborative effort to bring this innovative treatment to fruition.

Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, has been a cornerstone in cancer treatment, leveraging the body’s immune system to combat tumors. This approval adds to a robust global development program that spans numerous clinical trials across multiple cancer types. Since its initial approval in July 2014, Opdivo has been widely adopted, being approved in over 65 countries, including the United States, the European Union, Japan, and China.

The new formulation promises to expand its reach and impact, offering patients a more convenient method to receive treatment while maintaining clinical effectiveness. As the landscape of cancer treatment continues to evolve, innovations like Opdivo SC underscore the importance of patient-centered approaches and the role of cutting-edge research in advancing healthcare solutions.