#United States #San Diego #Halozyme #ENHANZE #RYBREVANT

European Commission Approves RYBREVANT® with ENHANZE®

On April 7, 2025, Halozyme Therapeutics, Inc., a biopharmaceutical company based in San Diego, announced a significant milestone in cancer treatment. The European Commission (EC) has granted marketing authorization for the subcutaneous formulation of RYBREVANT® (amivantamab) combined with LAZCLUZE® (lazertinib) for adult patients suffering from advanced non-small cell lung cancer (NSCLC). This decision marks a crucial advancement for patients with specific epidermal growth factor receptor (EGFR) mutations, including exon 19 deletions and exon 21 L858R substitutions.

Key Benefits of the Approval

The approved treatment not only represents an advancement in administering RYBREVANT® but also highlights a substantial improvement in the delivery method. The subcutaneous formulation co-formulated with Halozyme's proprietary ENHANZE® drug delivery technology allows for a less invasive approach compared to traditional intravenous methods. This innovative delivery system is designed to enhance patient comfort and adherence by providing a faster and simplified administration process.

In addition to its combination therapy use, RYBREVANT® is also approved as a standalone treatment for adult patients with advanced NSCLC involving specific EGFR exon 20 insertion mutations when previous platinum-based therapies have failed.

Strong Clinical Evidence

The EC approval was bolstered by encouraging data from the Phase 3 PALOMA-3 study (NCT05388669), which assessed the efficacy of the subcutaneous RYBREVANT® formulation. Results indicated a significant reduction in administration time and a decrease in infusion-related reactions. Dr. Helen Torley, the President and CEO of Halozyme, expressed enthusiasm regarding the approval, noting that such advancements could have a positive influence on the healthcare system, making treatment more accessible and manageable for patients.

Impact on Patients and Healthcare Providers

The implications of this approval reach far beyond clinical settings. With the innovative co-formulation approach, healthcare providers can expect to see a reduction in treatment burdens on both patients and the healthcare system. The potential for decreased administration time not only enhances the patient experience but also helps optimize workflow for healthcare professionals involved in the treatment process.

About Halozyme

Halozyme Therapeutics is at the forefront of developing disruptive therapeutic solutions aimed at improving patient outcomes. The company is the pioneer of the ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of medicines, thereby offering commercial and functional advantages in drug administration.

Since its inception, Halozyme has successfully impacted over one million patients globally through its innovative delivery solutions, with its technology utilized in nine commercialized products across more than 100 markets worldwide. The company collaborates with numerous leading pharmaceutical and biotechnology firms, including Roche, Takeda, and Pfizer, further extending its reach and impact on patient care.

Future Directions

The pathway forward appears promising for Halozyme as they continue to engage in research and collaborations aimed at expanding the potential applications of ENHANZE® technology. The recent approval serves as a testament to the company's commitment to patient-centric solutions in oncology and beyond, paving the way for enhanced therapeutic options and improved everyday experiences for patients.

In closing, the EU's endorsement of the subcutaneous RYBREVANT® formulation represents a transformative step in the treatment landscape for non-small cell lung cancer, setting a new standard in patient care and drug delivery innovations.