FDA Approves J&J Head and Neck Cancer Shot After 42% Respond

The US Food and Drug Administration has granted accelerated approval to Rybrevant Faspro, a Johnson & Johnson drug. It is for adults with head and neck cancer that has come back or spread. The approval went to Janssen Biotech, part of Johnson & Johnson, on Nov. 5, 2026.

What happened

The drug combines amivantamab with hyaluronidase and is given as an injection under the skin. It is approved for recurrent or metastatic head and neck squamous cell carcinoma that got worse during or after platinum chemotherapy and an anti-PD-(L)1 antibody. It is not approved for HPV-associated oropharyngeal cancer.

The FDA based its decision on the OrigAMI-4 trial, an open-label study with several groups of patients. In 102 patients, the overall response rate was 42%, meaning tumours shrank or disappeared. Among patients who responded, 56% had a response that lasted at least six months.

• Complete responses: 15% of patients, according to OncLive.
• Partial responses: 28% of patients, OncLive reported.
• Dosing: a weight-based dose under the skin every three weeks until the disease grows or side effects become too much, the FDA said.

The drug had Breakthrough Therapy designation and priority review. Its warnings include allergic and injection reactions, lung inflammation, skin reactions, eye problems and harm to an unborn baby.

Why it matters

The FDA said current approved treatments for these patients have a response rate of around 20% or less. It called this the first approval in 10 years of a drug for people with this cancer who had prior platinum chemotherapy.

Accelerated approval rests on response rate and how long responses last. The FDA said it is not yet known if this will mean a real benefit in long-term outcomes. It has required confirmatory studies.

What it means for people in the industry

There is a Canadian angle. The FDA reviewed the drug under Project Orbis, a program it shares with other regulators. Health Canada was one of the partners, along with agencies in Brazil, Israel and Singapore. The FDA said the applications may still be under review at those agencies.

The next thing to watch is the confirmatory work. Continued US approval may depend on a phase 3 trial confirming the benefit, OncLive reported, citing Johnson & Johnson. This is not medical advice. Patients should talk with their care team about treatment options.

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Sources

• FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma, US Food and Drug Administration
• FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma, US Food and Drug Administration
• FDA Approves Amivantamab and Hyaluronidase for Metastatic HNSCC, OncLive