FDA Grants Accelerated Approval for Head and Neck Cancer

Amivantamab and hyaluronidase-lpuj is approved for recurrent or metastatic head and neck squamous cell carcinoma that progressed after prior chemotherapy and immunotherapy.

Updated on Nov. 5, 2026 in Cancer

Bold flat-color editorial illustration of a single unlabeled glass vial beside a cluster of pale geometric spheres, in deep red and cream, evoking a new cancer treatment option. — The U.S. Food and Drug Administration granted accelerated approval on November 5 to Rybrevant Faspro for advanced head and neck squamous cell carcinoma that progressed after chemotherapy and immunotherapy. AI Illustration. Upload story photo >

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The U.S. Food and Drug Administration granted accelerated approval on November 5, 2026, to amivantamab and hyaluronidase-lpuj, marketed as Rybrevant Faspro by Janssen Biotech, Inc. The approval covers adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody.

Why it matters

The approval gives patients with advanced head and neck squamous cell carcinoma a new treatment option after standard therapies have stopped working. It was granted under accelerated approval, which means continued benefit must be confirmed in further study.

The approval rests on the OrigAMI-4 trial, in which 42% of 102 patients achieved an overall response rate (95% CI: 32%, 52%) and 56% of responders had a response lasting 6 months or longer. The trial did not include a comparator arm in the reported figures, and longer-term durability remains unconfirmed.

The players

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating drugs and biologics in the United States, which granted the accelerated approval.

Janssen Biotech, Inc.

The biopharmaceutical company that markets amivantamab and hyaluronidase-lpuj as Rybrevant Faspro.

The details

Patients received single-agent weight-based amivantamab and hyaluronidase-lpuj subcutaneously every 3 weeks until disease progression or unacceptable toxicity. Tumor response was assessed by blinded independent central review according to RECIST v1.1.

November 5, 2026: FDA granted accelerated approval to amivantamab and hyaluronidase-lpuj.

Cancer Treatment Landscape

The approval applies the FDA's accelerated approval pathway, which allows authorization on interim response data with confirmatory trials required afterward, to a head and neck cancer indication where patients have exhausted platinum chemotherapy and anti-PD-(L)1 therapy. It extends a treatment approach already used in other cancers to this disease setting.

Patients with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed after prior chemotherapy and immunotherapy may now have access to this treatment option. Because the approval excludes HPV-associated oropharyngeal squamous cell carcinoma, patients with that subtype should confirm eligibility with their care team.

The takeaway

Accelerated approvals can bring new options to patients sooner, but the response data behind them are preliminary until confirmatory trials report. Readers following this drug should watch for longer follow-up on how long responses last.