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FDA Accelerated Approval for Amivantamab in Head and Neck Cancer: Who Was in the 42% Study?

ByLife Choice Note

Short answer: On November 5, 2026, the US FDA granted accelerated approval to subcutaneous amivantamab and hyaluronidase-lpuj for a narrowly defined group of adults with recurrent or metastatic head and neck squamous cell carcinoma. Their cancer had to progress on or after both platinum chemotherapy and an anti-PD-(L)1 antibody. The indication does not include HPV-associated oropharyngeal squamous cell carcinoma.

  • FDA announcement: November 5, 2026
  • Region: United States
  • Population: Adults with recurrent or metastatic HNSCC after platinum chemotherapy and anti-PD-(L)1 therapy
  • Excluded: HPV-associated oropharyngeal squamous cell carcinoma identified through p16 testing
  • Evidence: A 102-person, multicenter, open-label, noncomparative phase 1b/2 OrigAMI-4 cohort

What does a 42% response rate mean?

Blinded independent central review using RECIST 1.1 found confirmed complete or partial tumor responses in 43 of 102 participants, for an objective response rate of 42% (95% CI, 32% to 52%). Fifteen participants, or 15%, had a complete response and 28, or 27%, had a partial response.

This is not a 42% cure rate. Objective response describes the proportion whose tumors shrank by a prespecified amount on imaging. Among the 43 responders, 24—56%—had a response lasting at least six months. At a median follow-up of 11.8 months, median duration of response had not yet been reached.

Did the study prove longer survival?

No. OrigAMI-4 did not randomly assign participants to amivantamab or another treatment. Median progression-free survival was 6.8 months and median overall survival was 12.5 months, but the single-arm design cannot show how much survival was extended because of the drug.

FDA’s accelerated approval pathway can allow earlier access based on a surrogate endpoint reasonably likely to predict clinical benefit in a serious condition. Here, tumor response rate and response duration supported the decision. Continued approval may depend on verification of clinical benefit in a confirmatory trial.

Does the approval apply to every head and neck cancer?

No. The population was not all head and neck cancers. It was recurrent or metastatic squamous cell carcinoma that had already progressed after platinum chemotherapy and checkpoint inhibition. The findings do not establish benefit for newly diagnosed localized disease, tumors treatable with surgery or radiation, or other histologic types.

HPV-associated oropharyngeal cancer is specifically outside this indication. The study excluded p16-positive oropharyngeal tumors. Primary site, HPV or p16 status, and complete treatment history therefore matter.

What is the treatment and how was it given?

Amivantamab is a bispecific antibody targeting EGFR and MET. In this indication, it is combined with hyaluronidase-lpuj in a weight-based subcutaneous formulation administered every three weeks until disease progression or unacceptable toxicity.

A US approval does not automatically establish approval, reimbursement, or availability in another country. Patients outside the United States need to check local regulatory status, supply, and coverage.

Important safety information

FDA lists warnings and precautions for hypersensitivity and administration-related reactions, interstitial lung disease or pneumonitis, dermatologic reactions, ocular toxicity, and embryo-fetal toxicity. New breathing symptoms, fever, severe skin reactions, or vision changes may require prompt assessment.

This article does not advise starting, stopping, or switching cancer treatment. Decisions require review of tumor site and histology, HPV or p16 status, prior therapies, performance status, organ function, risks, and patient preferences.

Important limitations

  • The evidence came from 102 participants in an open-label, single-arm study without a randomized comparator.
  • The 42% result is an imaging-based response rate, not a cure rate or proof of survival benefit.
  • The observed median overall survival of 12.5 months cannot be attributed to treatment through historical comparisons alone.
  • HPV-associated oropharyngeal cancer and prior anti-EGFR treatment were excluded, narrowing generalizability.
  • Confirmatory and longer-term safety and durability evidence is still needed.

Primary sources

Written by: Life Choice Note — an independent personal health-information explainer based on the FDA notice and original study.

Reviewed: November 6, 2026

Notice: This is not a diagnosis or cancer-treatment instruction. Treatment eligibility should be reviewed with the treating oncology team.

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