New Drug Offers Option for Advanced Head, Neck Cancer

Adults whose head and neck cancer kept growing after chemotherapy and immunotherapy now have a new treatment option.

Updated on Nov. 5, 2026 in Cancer

New Drug Offers Option for Advanced Head, Neck Cancer

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The FDA granted accelerated approval on November 5, 2026, to amivantamab and hyaluronidase-lpuj, marketed as Rybrevant Faspro by Janssen Biotech, for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The approval does not cover HPV-associated oropharyngeal squamous cell carcinoma.

Why it matters

For adults with this advanced form of head and neck cancer who have already run through standard chemotherapy and immunotherapy, the approval adds a new treatment option at a point where few alternatives remain. Because it is an accelerated approval, it rests on early response data rather than a confirmed improvement in survival.

The approval rests on OrigAMI-4, an open-label, multicenter, multi-cohort trial in 102 patients with recurrent or metastatic head and neck squamous cell carcinoma, with responses assessed by blinded independent central review. The overall response rate was 42% (95% CI: 32%, 52%), and 56% of responders had a response lasting at least six months.

The players

U.S. Food and Drug Administration (FDA)

The federal agency that regulates drugs and biologics in the United States and grants approvals such as this accelerated approval.

Janssen Biotech, Inc.

The Johnson & Johnson subsidiary that markets Rybrevant Faspro, a company known for its oncology portfolio including multiple myeloma and lung cancer therapies.

The details

Amivantamab is an antibody that targets the EGFR and MET receptors on cancer cells, and the hyaluronidase-lpuj component allows it to be given under the skin rather than only by intravenous infusion. In the trial, patients received it as a single agent every three weeks until their disease progressed or side effects became unacceptable. Tumor shrinkage was judged against RECIST v1.1 criteria by reviewers blinded to treatment assignment.

November 5, 2026: FDA grants accelerated approval for amivantamab and hyaluronidase-lpuj.

Health Landscape

Accelerated approval under the FDA's 1992 expedited pathway lets advanced-cancer drugs reach patients on response data before survival benefit is confirmed. For head and neck cancer, which has few options after chemotherapy and immunotherapy fail, this approval extends that pattern to a newly defined treatment setting.

If you or someone you care about has head and neck cancer that has continued to grow after chemotherapy and immunotherapy, this is a treatment option worth raising with an oncologist. The approval excludes HPV-associated oropharyngeal cancer, so the cancer's specific type and biomarkers matter for eligibility.

The takeaway

A response rate of 42% in a heavily pretreated group is a meaningful signal, but the accelerated approval means survival benefit is still being confirmed. Anyone weighing treatment options for advanced head and neck cancer should discuss eligibility and trial data with their oncology team.