The US Food and Drug Administration (FDA) has granted Priority Review to Johnson & Johnson’s supplemental Biologics License Application (sBLA) for subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) to treat adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
If approved, the therapy would offer a new treatment option for patients whose disease has progressed after platinum-based chemotherapy and treatment with a PD-1 or PD-L1 inhibitor.
Priority Review is granted to medicines that have the potential to significantly improve treatments for serious conditions, reducing the review timeline to about six months.
RYBREVANT FASPRO is currently approved in more than 40 countries, including the US, Europe and Japan, for the subcutaneous treatment of non-small cell lung cancer. The therapy is also being evaluated in additional tumour types as part of Johnson & Johnson’s broader oncology development programme.
The FDA’s decision is supported by findings from the pivotal Phase 1b/2 OrigAMI-4 trial, which showed that 42 per cent of patients receiving subcutaneous amivantamab as monotherapy responded to treatment, with more than one-third of responders achieving a complete response.
The trial excluded patients with HPV-related oropharyngeal squamous cell carcinoma and those who had previously received anti-EGFR therapy.
Yusri Elsayed, global therapeutic area head, oncology, Johnson & Johnson, said, “One of the hardest things about advanced head and neck cancer is that it can impact our most basic functions, like the ability to speak, eat and even breathe easily, profoundly affecting patients’ daily lives. For those whose disease progresses despite prior treatment, that burden is compounded by limited treatment options and poor outcomes.”
“Building on the established role of subcutaneous amivantamab in lung cancer, this milestone underscores its continued potential across multiple tumour types and reflects our commitment to bringing innovative treatment options to patients with cancers driven by EGFR and MET pathways,” Elsayed added.
Subcutaneous amivantamab is designed to target both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) while also engaging the immune system.
This dual-target approach is intended to address recurrent or metastatic HNSCC, where overexpression of EGFR and MET is found in 80–90 per cent of tumours and is associated with disease progression and treatment resistance.
Head and neck squamous cell carcinoma (HNSCC) is the most common type of head and neck cancer. It is believed to be the seventh most common cancer worldwide, accounting for around 4.5 per cent of all cancer cases.
The disease is primarily linked to tobacco use, alcohol consumption and infection with high-risk human papillomavirus (HPV).
