Subcutaneous amivantamab received accelerated approval for recurrent or metastatic head and neck cancer after platinum chemotherapy and immunotherapy

1. Amivantamab and hyaluronidase-lpuj (Rybrevant Faspro) received accelerated approval for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) after platinum-based chemotherapy and immunotherapy.

2. In an open-label trial of 102 patients, the overall response rate was 42%; among responders, 56% had responses lasting six months or longer.

Evidence Rating Level: 2 (Good)

2MM Brief: The U.S. Food and Drug Administration (FDA) granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic HNSCC whose disease progressed on or after platinum-based chemotherapy and immunotherapy. Approval was based on overall response rate and duration of response, which the FDA described as surrogate or intermediate endpoints; confirmatory studies are required to verify and describe clinical benefit. In an open-label, multicenter clinical trial involving 102 patients with recurrent or metastatic HNSCC, the overall response rate was 42%, meaning tumors decreased in size or disappeared. Among patients who responded, 56% had a response lasting six months or longer. The FDA said currently approved therapies are associated with an overall response rate of around 20% or less, but the source did not identify a specific comparator treatment or provide comparative trial data. Rybrevant Faspro is not indicated for oropharyngeal squamous cell carcinoma associated with human papillomavirus (HPV). Warnings and precautions for single-agent treatment include hypersensitivity and administration-related reactions, interstitial lung disease (ILD)/pneumonitis, dermatologic adverse reactions, ocular toxicity and harm to an unborn baby. The FDA granted the approval to Janssen Biotech, Inc., and also granted Breakthrough Therapy designation for this indication. The study was open-label, and the available results come from an agency announcement rather than a peer-reviewed journal publication; long-term clinical benefit remains unconfirmed, and the source did not report overall survival or other long-term outcomes. This approval provides an additional treatment option for the specified population, although confirmatory studies are needed to establish clinical benefit beyond response and response duration.

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