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A new option for head and neck cancer patients just got the FDA's stamp of approval. The agency granted accelerated approval to amivantamab and hyaluronidase (Rybrevant Faspro) for adults with recurrent or metastatic HNSCC that progressed after platinum-based chemo and anti-PD-1/PD-L1 therapy. In the OrigAMI-4 trial, the drug delivered a 42% overall response rate — a notable win in a disease with historically limited options.
The FDA has granted accelerated approval to amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) for adult patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed on or after platinum-based chemotherapy and an anti-PD-1/PD-L1 antibody. This marks a significant milestone in a cancer type where treatment options have long been scarce and outcomes remain poor.
The approval is based on data from the phase 1b/2 OrigAMI-4 trial, where the subcutaneous agent — which targets both EGFR and MET — showed meaningful efficacy across 102 patients. The safety profile was consistent with amivantamab's established track record, with no new signals identified.
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Why it matters: Continued approval hinges on the ongoing phase 3 OrigAMI-5 trial, which is evaluating amivantamab in combination with carboplatin and pembrolizumab in the first-line metastatic HNSCC setting. For now, this approval gives patients and oncologists a new, biologically targeted tool in a space that has desperately needed one.
