Johnson & Johnson (J&J) has received accelerated US Food and Drug Administration (FDA) approval for its bispecific antibody drug, Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), to treat adults with advanced head and neck squamous cell carcinoma (HNSCC). The approval offers a new treatment option for patients whose cancer has progressed despite standard chemotherapy and immunotherapy.
This latest approval expands the drug’s use beyond lung cancer, where Rybrevant was initially approved in 2021 for certain cases of non-small cell lung cancer (NSCLC).
How Does Rybrevant Faspro Work?
Rybrevant is a bispecific antibody that targets two receptors, epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET). Both receptors can contribute to cancer growth and treatment resistance.
By blocking these two targets simultaneously, the drug aims to prevent cancer cells from developing resistance to treatment. The therapy is designed for patients who have experienced disease progression during or after currently available standard treatments.
Faster Administration Through Subcutaneous Injection
Rybrevant Faspro uses drug-delivery technology developed by Halozyme, allowing healthcare professionals to administer the treatment through a subcutaneous injection rather than an intravenous infusion.
The injectable formulation takes approximately five minutes to administer, compared with two to five hours for the intravenous version. This shorter administration time could make treatment more convenient for patients and healthcare providers.
Clinical Trial Results Support FDA Approval
The FDA granted accelerated approval based on results from a Phase 1b/2 clinical trial evaluating Rybrevant in patients with advanced head and neck cancer.
The study reported an overall response rate of 42%, with 15% of patients achieving a complete response. Furthermore, 56% of patients who responded to treatment maintained their response for more than six months.
A Phase 3 clinical trial is currently underway to confirm the treatment’s clinical benefits and potentially support its use as a first-line treatment for head and neck cancer.
However, the latest approval does not cover patients with HPV-associated oropharyngeal squamous cell carcinoma.
J&J Expands Its Oncology Portfolio
The latest FDA decision marks another step in J&J’s oncology growth strategy. The company has continued expanding the Rybrevant franchise beyond its initial lung cancer indications.
During the first nine months of 2026, global sales of Rybrevant and Lazcluze reached $866 million, representing a 67.4% increase compared with the same period in 2025. J&J has also projected that Rybrevant could achieve peak annual sales of $5 billion.
The accelerated approval could expand access to targeted treatment for patients with advanced head and neck cancer who have limited therapeutic options. As reported by medcitynews.com, the US FDA has granted accelerated approval to J&J’s Rybrevant Faspro, expanding its use to adults with advanced head and neck cancer and offering a new targeted treatment option for patients whose disease has progressed despite standard therapies.