Halozyme and Bristol Myers Squibb Secure European Commission Approval for Subcutaneous Opdivo Co-Formulated with ENHANZE in Multiple Solid Tumors
Halozyme Therapeutics celebrates a significant regulatory milestone as Bristol Myers Squibb gains European Commission approval for a new subcutaneous formulation of Opdivo®, designed to offer cancer patients a faster and more convenient treatment experience.
Halozyme Therapeutics,a biotechnology company pioneering innovative drug delivery technologies, announced on May 28, 2025, that its long-standing partner Bristol Myers Squibb has received European Commission (EC) approval for a novel subcutaneous (SC) formulation of Opdivo® (nivolumab), co-formulated with Halozyme’s proprietary ENHANZE® drug delivery technology. This new formulation is approved for use across a wide range of adult solid tumor indications, marking a major step forward in patient-centered oncology care throughout Europe.
The subcutaneous version of Opdivo is now authorized for administration as monotherapy, as maintenance monotherapy following the completion of intravenous (IV) nivolumab plus Yervoy® (ipilimumab) combination therapy, and in combination with chemotherapy or with cabozantinib. With the EC’s green light, eligible patients across the European Union’s 27 member states, as well as in Iceland, Liechtenstein, and Norway, will have access to this new mode of immunotherapy delivery.
A Shift Toward Patient Convenience in Oncology Treatment
Traditionally, immuno-oncology drugs such as Opdivo have been administered intravenously, requiring infusion appointments that often last 30 minutes or more and necessitate the use of clinical infusion centers. The newly approved subcutaneous formulation, developed with ENHANZE®—Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20)—allows for the drug to be delivered under the skin in as little as 3 to 5 minutes. This substantially reduces the treatment burden on patients and healthcare systems.
“The European approval of Opdivo SC represents an advancement for certain cancer patients, who now have the option to receive their Opdivo as a 3-to-5-minute SC injection,” said Dr. Helen Torley, president and CEO of Halozyme. “This approval is just one of the 11 growth catalysts for our commercialized SC products expected this year.”
The shift to subcutaneous administration has gained increasing momentum in oncology and other therapeutic areas, driven by both patient preference for less invasive, shorter-duration treatments and healthcare provider demand for more efficient drug delivery models. With the EC’s decision, the innovation behind ENHANZE is again validated as a transformative tool for reimagining the patient experience.
Backed by Robust Clinical Evidence from the CheckMate -67T Trial
The EC approval is based on data from the pivotal Phase 3 CheckMate -67T clinical trial, which evaluated the pharmacokinetics, efficacy, and safety of the subcutaneous Opdivo formulation compared to its intravenous counterpart. The study showed that subcutaneous Opdivo achieved non-inferior levels of nivolumab exposure relative to IV administration, while maintaining comparable safety and efficacy profiles.
Although full details of the trial were not included in Halozyme’s announcement, Bristol Myers Squibb previously released topline results indicating that the SC version preserved the therapeutic benefit of the IV formulation, with no new safety signals observed. These findings underpin regulatory confidence in the clinical viability of the subcutaneous formulation.
The new approval adds a valuable treatment option for oncologists and patients, enabling clinicians to tailor immunotherapy delivery based on individual needs and clinical contexts. Whether used alone, as part of a maintenance strategy, or in combination with other agents, subcutaneous Opdivo now offers a convenient and effective alternative for managing a wide range of solid tumors.
A Testament to the Strength of Strategic Collaboration
The successful development and approval of subcutaneous Opdivo highlights the strategic collaboration between Halozyme and Bristol Myers Squibb, which has sought to integrate ENHANZE technology into a growing number of therapeutics. ENHANZE enables subcutaneous delivery by temporarily degrading hyaluronan in the subcutaneous space, facilitating the dispersion and absorption of biologics that would otherwise require IV infusion.
For Halozyme, the approval represents another milestone in its journey to expand the reach of ENHANZE and to grow its royalty revenue base through high-value partnerships. ENHANZE is currently used in multiple commercial products, and Halozyme continues to collaborate with several global pharmaceutical companies, including Roche, Pfizer, Janssen, and Takeda, to broaden the impact of subcutaneous drug delivery.
“This approval reflects the success of our long-term strategy to deliver meaningful improvements in drug delivery that can benefit patients and improve healthcare efficiency,” Torley added.
A Dual Regulatory Milestone: FDA Approval in the U.S. Also Achieved
The EC approval follows on the heels of a similar regulatory milestone in the United States. On December 27, 2024, the U.S. Food and Drug Administration (FDA) approved subcutaneous nivolumab co-formulated with ENHANZE, marketed under the brand name Opdivo Qvantig™, for the treatment of certain adult patients with non-small cell lung cancer (NSCLC). The U.S. approval marked the first time a subcutaneous formulation of an anti-PD-1 immune checkpoint inhibitor had been cleared by the FDA.
With regulatory approvals now secured in both the U.S. and the European Union, Bristol Myers Squibb is positioned to expand access to subcutaneous Opdivo in major global markets. This dual success reflects a broader industry trend toward making cancer treatment more patient-friendly through innovative delivery mechanisms.
Halozyme’s Growth Trajectory Strengthened by ENHANZE’s Expansion
Halozyme’s business model is heavily supported by royalty revenues and milestone payments from its partners who license ENHANZE. As of 2025, the company has more than a dozen active ENHANZE collaborations in place and expects significant revenue growth as its partners achieve regulatory milestones and launch subcutaneous versions of blockbuster biologics.
In the context of Halozyme’s 2025 strategic roadmap, the EC approval of subcutaneous Opdivo represents one of 11 key commercial catalysts that the company has identified as drivers of near-term and long-term growth. Each new product approval that incorporates ENHANZE brings Halozyme closer to achieving its goal of transforming drug delivery across therapeutic areas.
ENHANZE’s ability to convert IV therapies into subcutaneous injections is particularly compelling in the age of value-based care and patient-centered medicine. By offering a more convenient, faster mode of drug administration, ENHANZE-enabled products may help reduce healthcare costs, improve adherence, and enhance overall treatment experiences.
With the EC’s approval of subcutaneous Opdivo, co-formulated with Halozyme’s ENHANZE technology, patients across Europe now have access to a more convenient form of a powerful immunotherapy. This milestone not only underscores the clinical and commercial value of subcutaneous drug delivery but also strengthens Halozyme’s position as a key enabler of innovation in the biopharmaceutical industry.
As the oncology field continues to evolve, the push toward less invasive, more patient-centric delivery models is expected to accelerate. The partnership between Halozyme and Bristol Myers Squibb offers a blueprint for how biopharmaceutical companies can work together to translate cutting-edge science into tangible benefits for patients and health systems worldwide.
In the months ahead, investors and stakeholders will be watching closely as Halozyme and its partners pursue additional regulatory filings, new product launches, and expanded indications for ENHANZE-enabled therapies. The successful commercialization of subcutaneous Opdivo in Europe could be just the beginning of a broader wave of ENHANZE-driven innovations that reshape the future of drug delivery in oncology and beyond.
