#United States #San Diego #Halozyme #ENHANZE #OPDIVO

CHMP's Positive Opinion for Opdivo® Subcutaneous Formulation

In a significant advancement for cancer treatment, Halozyme Therapeutics, Inc. has reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has provided a favorable opinion regarding the subcutaneous formulation of Opdivo® (nivolumab). This new formulation, developed in collaboration with Halozyme's proprietary ENHANZE® technology, aims to improve the treatment experience for patients with multiple solid tumor indications.

Details of the CHMP Opinion

Bristol Myers Squibb, the developer of Opdivo, received this positive opinion indicating that the subcutaneous version could be utilized as a standalone treatment or alongside established therapies such as Yervoy® (ipilimumab) and various chemotherapy options. The anticipation is that with subcutaneous delivery, patients will enjoy a faster and more flexible treatment option. It is particularly noteworthy considering the potential to ease the burden on healthcare systems, as subcutaneous administration could streamline the process and reduce time spent in medical facilities.

Dr. Helen Torley, Halozyme's president and CEO, expressed excitement about this development, emphasizing the expected benefits for patients undergoing cancer therapy. The company, by offering a one-stop solution through their ENHANZE® technology, aims to facilitate drug delivery while improving patient comfort and adherence.

Encouraging Results from Clinical Trials

The positive recommendation from the CHMP is grounded in the favorable outcomes observed during the Phase 3 CheckMate -67T trial. The trials not only demonstrated the effectiveness of the subcutaneous formulation but also showcased its potential to reduce treatment time significantly. Details on these results can be found in the press release by Bristol Myers Squibb dated March 28, 2025.

Next Steps in Approval Process

The CHMP's opinion will now proceed to the European Commission for review, which holds the authority to grant marketing authorization across the European Union. An official decision on this extension is anticipated by June 2, 2025. With the FDA having already approved Opdivo and the hyaluronidase formulation in the United States on December 27, 2024, this momentum is promising for the future rollout of the subcutaneous option in Europe.

About Halozyme

Halozyme, based in San Diego, CA, is at the forefront of biopharmaceutical innovation. The company specializes in disruptive solutions designed to enhance patient experiences and treatment outcomes. Their ENHANZE® drug delivery technology, which utilizes the recombinant human hyaluronidase enzyme (rHuPH20), paves the way for efficient subcutaneous administration of drugs and fluids. This innovative approach has already impacted over one million patients through nine products launched in over 100 markets around the globe.

Halozyme’s ENHANZE® technology is licensed to numerous leading pharmaceutical companies, including Roche, Pfizer, and Eli Lilly, reflecting its widespread acceptance and commercial validation in the healthcare industry. Additionally, Halozyme is dedicated to the development of drug-device combination products that further enhance patient convenience and treatment efficacy.

With a commitment to transforming patient care through innovative solutions, Halozyme continues to expand its footprint in the pharmaceutical sector, enhancing the quality of treatment for patients worldwide. This recent progression with Opdivo® stands as a testament to their ongoing efforts and dedication towards improving healthcare delivery.

For more details on Halozyme's initiatives and innovations, interested parties can visit their official website or follow them on LinkedIn and Twitter.