San Diego, California, USA, November 6, 2026

Halozyme Therapeutics, Inc. has announced an important regulatory milestone following the U.S. Food and Drug Administration (FDA) accelerated approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), developed by Johnson & Johnson and co-formulated using Halozyme’s proprietary ENHANZE® drug-delivery technology. The newly approved treatment is indicated for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed during or following platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication excludes patients with human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma. The approval represents an important expansion of RYBREVANT FASPRO beyond its established use in lung cancer and introduces the first dual-targeted therapy approved for this particular treatment setting. The combination of amivantamab and ENHANZE technology enables subcutaneous administration, offering patients a new treatment delivery option while demonstrating the growing importance of innovative drug-delivery platforms in modern oncology.

ENHANZE Technology Supports Subcutaneous Drug Delivery

Halozyme’s ENHANZE® technology is a proprietary drug-delivery platform based on recombinant human hyaluronidase PH20 (rHuPH20). The technology is designed to temporarily modify the extracellular matrix beneath the skin by breaking down hyaluronan, a naturally occurring component of subcutaneous tissue. This process facilitates the dispersion and absorption of injected therapeutic medicines, allowing certain drugs that would otherwise require intravenous administration to be delivered through a subcutaneous injection. In RYBREVANT FASPRO, ENHANZE technology is combined with amivantamab to support a convenient administration approach. The formulation is designed to reduce the time required for treatment administration, potentially lowering the logistical burden associated with hospital-based cancer care. RYBREVANT FASPRO can be administered through a subcutaneous injection in approximately five minutes, offering an alternative to longer intravenous infusion procedures. Halozyme highlighted that its ENHANZE platform has reached more than one million patients through ten commercialized products across over 100 global markets. The platform is licensed to several leading pharmaceutical and biotechnology companies, including Johnson & Johnson, Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb and argenx.

Dual EGFR and MET Targeting Expands Oncology Treatment

The FDA approval is particularly significant because RYBREVANT FASPRO simultaneously targets two important cancer-related pathways: epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET). These pathways play important roles in tumor growth, survival and progression in head and neck squamous cell carcinoma. Amivantamab is a fully human bispecific antibody designed to bind both EGFR and MET, while also supporting immune-cell-directed mechanisms against cancer cells. The regulatory decision was supported by results from the Phase 1b/2 OrigAMI-4 clinical trial, which evaluated the treatment in patients with previously treated recurrent or metastatic HNSCC. Among 102 patients in the primary efficacy population, the treatment demonstrated a confirmed overall response rate of 42%, including complete responses in 15% and partial responses in 28% of patients. Furthermore, 56% of patients who achieved a response maintained it for more than six months. These findings demonstrated clinically meaningful antitumor activity in a patient population with limited treatment options. The FDA granted Breakthrough Therapy Designation in February 2026, followed by Priority Review in July 2026, before granting accelerated approval on November 5, 2026.

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Halozyme Strengthens Its Pharmaceutical Technology Partnerships

The approval further highlights Halozyme’s role as a technology partner in the global biopharmaceutical industry. Rather than developing the cancer medicine independently, Halozyme contributes its proprietary drug-delivery platform through collaboration with pharmaceutical companies developing innovative therapies. Its ENHANZE technology is designed to improve the administration of injectable medicines and support treatment convenience across multiple therapeutic areas. According to Halozyme President and Chief Executive Officer Dr. Helen Torley, the approval expands the reach of RYBREVANT FASPRO into a patient population with significant unmet medical needs and demonstrates the contribution of ENHANZE technology to the availability of new subcutaneous treatment options. The company continues to expand its drug-delivery portfolio through additional technologies, including Hypercon™ and Aerocon™, which are being developed to support highly concentrated drug formulations and potentially broaden subcutaneous delivery applications. These technologies complement Halozyme’s established ENHANZE platform and reflect its broader strategy of developing solutions that can improve pharmaceutical product delivery. Overall, the FDA approval of RYBREVANT FASPRO represents a significant milestone for Halozyme Therapeutics and its ENHANZE drug-delivery platform. The development demonstrates how pharmaceutical technology partnerships can contribute to expanding treatment options, improving drug administration and supporting innovation in oncology. As demand for convenient and patient-focused therapies continues to grow, Halozyme’s technology platform could play an increasingly important role in the development and commercialization of next-generation biologic medicines.

Source: Halozyme Therapeutics press release