J&J wins FDA approval for Rybrevant Faspro in advanced head and neck cancer
The approval covers adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and treatment with an anti-PD-(L)1 antibody.
USA—The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J) accelerated approval for Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) to treat certain adults with recurrent or metastatic head and neck cancer, expanding the therapy’s use beyond lung cancer.
The approval covers adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and treatment with an anti-PD-(L)1 antibody.
Rybrevant Faspro is the first bispecific antibody targeting two cancer-related pathways to receive approval for this patient population.
HNSCC is the most common type of head and neck cancer.
It develops in tissues lining the mouth, throat and voice box, although cancers in the sinuses, nasal cavity and salivary glands also fall within the broader head and neck cancer category.
Dual-targeted approach
Rybrevant is a bispecific antibody that blocks two proteins involved in tumour growth: epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET).
These proteins are overexpressed in up to 90% of recurrent or metastatic HNSCC tumours, making them potential treatment targets.
While the original Rybrevant formulation is administered intravenously, Rybrevant Faspro combines amivantamab with recombinant human hyaluronidase developed by Halozyme Therapeutics.
This formulation allows healthcare professionals to administer the medicine through a subcutaneous injection.
By blocking EGFR and MET signalling, the therapy interferes with mechanisms that support cancer cell growth and division.
Clinical evidence supports accelerated approval
The FDA based its decision on results from the Phase Ib/II OrigAMI-4 trial (NCT06385080), which reported an overall response rate (ORR) of 42% among patients receiving Rybrevant Faspro.
The median time to first response was 6.6 weeks, while 56% of patients who responded maintained their response for more than six months.
Amanda Hollinger, executive director of the Head and Neck Cancer Alliance, highlighted the limited treatment options available to patients whose disease progresses after initial therapy.
She noted that recurrent or metastatic HNSCC can affect essential functions, including eating, speaking, swallowing and breathing, making additional treatment options important for patients and their families.
J&J also pointed to the ongoing Phase III OrigAMI-5 study, which is evaluating the therapy in first-line HNSCC.
The company expects the trial’s results to support discussions with the FDA on maintaining the accelerated approval.
Competition in the HNSCC market
The approval places J&J in a market that includes established immunotherapies such as MSD’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab).
Eli Lilly’s Erbitux (cetuximab) is another targeted treatment approved for HNSCC, although it acts only on EGFR, unlike Rybrevant, which blocks both EGFR and MET.
The new indication also represents Rybrevant Faspro’s first approved use outside lung cancer.
The therapy already has four approved indications in lung cancer, giving J&J an established commercial base from which to expand its oncology portfolio.
J&J has identified Rybrevant as a key contributor to its longer-term oncology growth strategy.
The company aims to generate US$50bn in annual oncology sales by 2030, with additional indications expected to broaden the drug’s commercial reach.
GlobalData forecasts that Rybrevant will generate US$2.6bn in global sales in 2030.
However, this forecast does not yet account for the addition of the HNSCC indication
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