Johnson & Johnson (NYSE: JNJ) announced that the US FDA has granted Priority Review to the supplemental Biologics License Application (sBLA) for amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed following platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The designation shortens the FDA review timeline to approximately six months and marks the first potential expansion of the bispecific antibody beyond non-small cell lung cancer (NSCLC), where it holds multiple approvals.
The sBLA is supported by pivotal data from Cohort 1 of the Phase Ib/II OrigAMI-4 study (NCT06385080), presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the Journal of Clinical Oncology on May 31, 2026. In 102 patients with HPV-unrelated recurrent or metastatic HNSCC — excluding those with prior anti-epidermal growth factor receptor (EGFR) therapy or HPV-positive oropharyngeal cancer — blinded independent central review confirmed an overall response rate (ORR) of 42% (95% CI, 32–52), with complete responses in 15% of patients and partial responses in 27%. The clinical benefit rate was 63%. At a median follow-up of 11.8 months (data cutoff March 18, 2026), median duration of response had not been reached, with 63% of responses ongoing. Median progression-free survival was 6.8 months and median overall survival was 12.5 months. Median time to first response was 6.4 weeks. Treatment-related discontinuations occurred in 8% of patients, with no new safety signals relative to prior amivantamab experience.
Amivantamab is a fully human bispecific antibody that simultaneously targets EGFR and mesenchymal-epithelial transition (MET) receptors, both of which are overexpressed in 80–90% of HNSCC tumors and are implicated in tumor growth and resistance to prior therapy. Co-formulation with recombinant human hyaluronidase PH20 — Halozyme's ENHANZE drug delivery technology — enables subcutaneous administration. The dual-pathway mechanism differentiates it from monospecific anti-EGFR agents such as cetuximab, which does not address MET-mediated resistance.
The Priority Review follows a Breakthrough Therapy Designation (BTD) granted in February 2026 for the same indication, based on earlier OrigAMI-4 data presented at the 2025 European Society for Medical Oncology (ESMO) Congress. Together, the two designations reflect a consistent regulatory trajectory for the program in HPV-unrelated HNSCC, a population with limited options after progression on immunotherapy and platinum chemotherapy, where five-year survival in the recurrent or metastatic setting is approximately 15%.