FDA Grants J&J Bispecific Accelerated Approval for Head and Neck Cancer

On 5 November 2026, the US Food and Drug Administration granted accelerated approval to Rybrevant Faspro, a subcutaneous form of the bispecific antibody amivantamab. The drug acts on two cancer-growth pathways, EGFR and MET. The label covers adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. It is the drug's first approved use outside lung cancer.

The decision draws on OrigAMI-4, a Phase 1b/2 trial in which 42% of patients responded to treatment, including complete responses in 15%. The FDA said the label excludes HPV-associated oropharyngeal squamous cell carcinoma. A confirmatory trial could later support first-line use. The reporting does not address regulatory status or access in India.