Halozyme Announces Positive CHMP Opinion for Bristol Myers Squibb’s Subcutaneous Opdivo® with ENHANZE
Halozyme Therapeutics, Inc. (NASDAQ: HALO) recently announced a significant milestone in oncology treatment development, as Bristol Myers Squibb has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation supports the approval of a new subcutaneous (SC) formulation of Opdivo® (nivolumab), developed using Halozyme’s proprietary ENHANZE® drug delivery technology. This formulation is designed for use across multiple previously approved adult solid tumors, whether as a monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
Regulatory Milestone and European Commission Review
The CHMP’s positive opinion represents a crucial step toward expanding the availability of this innovative therapy to cancer patients in the European Union (EU). The European Commission (EC) now has the responsibility to review the CHMP’s recommendation and make a final decision regarding marketing authorization for the SC formulation of Opdivo. A verdict from the EC is expected by June 2, 2025, determining whether this novel treatment approach will become widely available in the EU.
The approval process for pharmaceutical products in the EU involves rigorous scientific evaluation by the EMA, and a positive CHMP opinion often signals a strong likelihood of regulatory approval. If the EC grants marketing authorization, the new SC formulation of Opdivo will be accessible across all EU member states, significantly impacting cancer treatment delivery in the region.
Enhancing Patient Convenience and Healthcare Efficiency
One of the key advantages of the subcutaneous formulation of Opdivo is the potential to improve patient experience and streamline healthcare system efficiencies. Traditional intravenous (IV) infusions can be time-consuming and resource-intensive, requiring patients to spend extended periods in infusion centers. By contrast, the SC formulation offers a faster and more convenient alternative, allowing for shorter administration times and potentially reducing the burden on healthcare facilities and professionals.
Dr. Helen Torley, president and chief executive officer of Halozyme, emphasized the importance of this development, stating, “We are delighted that the subcutaneous formulation of Opdivo developed with Halozyme’s ENHANZE drug delivery technology was recommended for approval in the European Union. Subcutaneous delivery of Opdivo would provide cancer patients a faster and more flexible treatment option and may help alleviate pressure on healthcare system resources.”
Halozyme’s ENHANZE technology is based on recombinant human hyaluronidase enzyme (rHuPH20), which facilitates the dispersion and absorption of co-administered drugs when delivered subcutaneously. This innovative technology has the potential to revolutionize the administration of biologics by reducing infusion times and increasing patient comfort.
Clinical Validation: Phase 3 CheckMate -67T Trial
The CHMP’s recommendation is supported by robust clinical data from the Phase 3 CheckMate -67T trial. This pivotal study evaluated the efficacy and safety of the subcutaneous formulation of Opdivo compared to its intravenous counterpart. The findings demonstrated that the SC formulation maintains comparable efficacy and safety profiles while offering enhanced convenience for patients.
The full results of the CheckMate -67T trial were detailed in Bristol Myers Squibb’s press release issued on March 28, 2025. The study’s positive outcomes reinforce the potential benefits of transitioning from IV to SC administration for nivolumab in the oncology treatment paradigm.
U.S. Approval and Global Expansion
The regulatory progress in Europe follows a significant milestone in the United States, where the U.S. Food and Drug Administration (FDA) approved the SC formulation of nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, on December 27, 2024. This approval marked a critical step in making subcutaneous nivolumab available to a broader patient population and providing an alternative to IV infusion.
With the U.S. and potential EU approval, Bristol Myers Squibb and Halozyme are poised to drive further adoption of the SC formulation in other global markets. Regulatory submissions in additional countries are expected, aligning with the companies’ commitment to expanding patient access to innovative oncology therapies worldwide.
Market Impact and Future Outlook
The introduction of the SC formulation of Opdivo represents a significant advancement in immuno-oncology. As a blockbuster drug, Opdivo has been a cornerstone of immune checkpoint inhibitor therapies, playing a crucial role in treating various cancers, including lung cancer, melanoma, renal cell carcinoma, and more. The availability of a subcutaneous option could further solidify its market position and enhance patient adherence by simplifying treatment administration.
Halozyme, which licenses its ENHANZE technology to multiple pharmaceutical companies, stands to benefit from increased adoption of SC formulations across various biologics. The success of Opdivo Qvantig could serve as a catalyst for broader applications of ENHANZE in other therapeutic areas.
Additionally, the shift toward subcutaneous administration aligns with broader industry trends favoring patient-centric drug delivery methods. Innovations in drug formulation that prioritize convenience and efficiency are gaining traction, particularly in oncology, where treatment regimens can be lengthy and burdensome for patients.
The CHMP’s positive opinion on the subcutaneous formulation of Opdivo represents a major step forward in improving cancer treatment accessibility Halozyme and efficiency. If approved by the European Commission, this new delivery option will offer patients a faster and more convenient alternative to intravenous administration, potentially transforming the way nivolumab is administered in clinical practice.
With FDA approval already secured and European regulatory review progressing, the future looks promising for Opdivo Qvantig. The anticipated regulatory green light from the European Commission in June 2025 could pave the way for broader global adoption, ultimately enhancing treatment outcomes and quality of life for cancer patients worldwide.
As the landscape of oncology treatment continues to evolve, the development of innovative drug delivery technologies like Halozyme’s ENHANZE will play an increasingly pivotal role in shaping the future of cancer care.
