FDA Grants Accelerated Approval to ENHANZE-Based RYBREVANT FASPRO for Head and Neck Cancer
Halozyme Therapeutics announced that Johnson & Johnson received U.S. FDA accelerated approval for RYBREVANT FASPRO, utilizing Halozyme’s ENHANZE technology. This dual-targeted therapy, which simultaneously targets EGFR and MET, is approved as a single-agent treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma following progression on platinum-based chemotherapy and an anti-PD-(L)1 antibody. This milestone represents the first approval of a dual-targeted therapy for this patient population, addressing significant unmet medical needs.
Halozyme Therapeutics, Inc. announced that Johnson & Johnson has received accelerated approval from the U.S. Food and Drug Administration for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with Halozyme’s ENHANZE® technology.
The FDA approved RYBREVANT FASPRO as a single-agent treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody.
According to the release, this is the first approval of a dual-targeted therapy in this setting. RYBREVANT FASPRO simultaneously targets epidermal growth factor receptor, or EGFR, and mesenchymal-epithelial transition, or MET.
Dr. Helen Torley, President and Chief Executive Officer of Halozyme, said the approval will further expand the reach of RYBREVANT FASPRO in a population with high unmet need.
This article may include AI-generated content that is human-reviewed, which is for reference and general information purposes only and does not constitute investment advice.
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