BOSTON–The U.S. Food and Drug Administration has granted accelerated approval to Johnson & Johnson’s RYBREVANT FASPRO for certain patients with advanced head and neck cancer, expanding the use of a treatment incorporating drug delivery technology developed by Halozyme Therapeutics, which maintains operations in Boston.
The approval covers RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) as a standalone treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma whose cancer has progressed during or after treatment with platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 antibody.
The authorization excludes patients with HPV-associated oropharyngeal squamous cell carcinoma, a form of cancer affecting the middle portion of the throat.
The FDA decision represents the first approval of a dual-targeted therapy for this specific patient population, with the treatment simultaneously targeting two proteins involved in cancer growth and progression: epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition factor (MET).
RYBREVANT FASPRO incorporates Halozyme’s ENHANZE drug delivery technology, which enables certain medications traditionally administered intravenously to be delivered through subcutaneous injection.
The technology uses a proprietary enzyme known as recombinant human hyaluronidase PH20 (rHuPH20), which temporarily modifies tissue beneath the skin to facilitate the absorption and distribution of injected medications.
The approach is designed to reduce treatment administration time and improve convenience for patients receiving complex biological therapies.
“This approval will further expand the reach of RYBREVANT FASPRO in a high unmet need population,” said Helen Torley, President and Chief Executive Officer of Halozyme Therapeutics. “We are pleased that our ENHANZE technology is helping bring a new subcutaneous treatment option to patients with advanced head and neck cancer.”
Head and neck squamous cell carcinoma is a form of cancer that develops in the cells lining areas such as the mouth, throat and larynx.
Treatment options can become limited when the disease returns or spreads after chemotherapy and immunotherapy, creating a need for additional therapies that target different mechanisms of cancer growth.
RYBREVANT FASPRO combines amivantamab, a bispecific antibody designed to target EGFR and MET, with hyaluronidase to enable subcutaneous administration.
By targeting both EGFR and MET, amivantamab is designed to interfere with signaling pathways that can contribute to tumor growth and survival.
The FDA’s accelerated approval pathway allows certain drugs addressing serious conditions and unmet medical needs to receive earlier authorization based on evidence considered reasonably likely to predict clinical benefit. Continued approval may depend on additional studies confirming the treatment’s effectiveness.
The new indication extends the use of RYBREVANT FASPRO beyond lung cancer, where amivantamab-based therapies have already been developed for specific patient populations.
For Halozyme, the authorization represents another commercial application of its ENHANZE platform, which is licensed to pharmaceutical and biotechnology companies developing injectable therapies.
The San Diego-headquartered company has operations in Boston, as well as Ewing, New Jersey, and Minnetonka, Minnesota.
Halozyme said its ENHANZE technology has been incorporated into 10 commercialized products across more than 100 markets worldwide, reaching more than one million patients.
The company has licensing partnerships with several major pharmaceutical manufacturers, including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol Myers Squibb, GSK, Incyte and others.
In addition to ENHANZE, Halozyme is expanding its drug delivery portfolio through technologies designed to increase the concentration of biologic medications and reduce the volume required for injections.
Its Hypercon microparticle technology is being developed to enable higher drug concentrations, potentially allowing certain therapies to be administered in smaller injection volumes.
The company has also added Aerocon, a polymer-based drug concentration platform intended to expand the range of biological medicines suitable for subcutaneous administration.
These technologies are designed to complement ENHANZE by addressing limitations associated with delivering large or highly concentrated biological drugs.
Halozyme also develops and manufactures drug-device combination products, including autoinjector technologies designed to simplify medication administration.
Its commercial product portfolio includes Hylenex and XYOSTED, along with partnered products and development programs involving Teva Pharmaceuticals and other pharmaceutical companies.
The FDA approval of RYBREVANT FASPRO for advanced head and neck cancer reflects the growing use of subcutaneous drug delivery technologies in oncology, where manufacturers are seeking ways to make complex biological treatments more convenient for patients and healthcare providers.
For eligible patients with recurrent or metastatic head and neck cancer who have exhausted certain standard treatment options, the newly authorized therapy provides an additional targeted treatment option, although continued authorization under the accelerated approval pathway may require confirmation of clinical benefit.
