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U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme's ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer

  • Johnson & Johnson received accelerated FDA approval for RYBREVANT FASPRO™ (amivantamab & hyaluronidase-lpuj) co-formulated with ENHANZE® as a single agent.
  • The approval treats adults with recurrent or metastatic head & neck squamous cell carcinoma (HNSCC) progressing after platinum-based chemotherapy & an anti-PD-(L)1 antibody.
  • The indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.
  • This represents the first dual-targeted therapy approval in this setting, targeting both epidermal growth factor receptor (EGFR) & mesenchymal-epithelial transition (MET).
  • Halozyme's ENHANZE® technology facilitates the subcutaneous delivery of the treatment to reduce patient burden.
  • Halozyme also utilizes Hypercon™ & Aerocon™ technologies to enable hyperconcentration of biologics for subcutaneous administration.
  • The company develops drug-device combination products using proprietary auto-injector technologies to improve convenience & adherence.
  • Halozyme is headquartered in San Diego, CA, with additional offices in Ewing, NJ; Minnetonka, MN; & Boston, MA.
Company
Halozyme Therapeutics, Inc.
Keywords
Halozyme Therapeutics, Inc.