Health

FDA approves first new drug in a decade for advanced head and neck cancer

Washington • November 6, 2026 • By Press Pass USA

A nurse in blue scrubs adjusting an IV infusion bag at a cancer treatment center

Photo: Johnson & Johnson

The Food and Drug Administration on Thursday granted accelerated approval to a new treatment for adults with recurrent or metastatic head and neck cancer — the first new drug approved for this group of patients in a decade.

The drug, amivantamab and hyaluronidase-lpuj, sold as Rybrevant Faspro, is for patients whose cancer has progressed after platinum-based chemotherapy and an anti-PD-(L)1 immunotherapy, the FDA said. It is given as a subcutaneous injection, rather than an intravenous infusion.

The approval rests on the results of the OrigAMI-4 trial, which enrolled 102 patients. In that study, 42 percent of patients saw their tumors shrink or disappear, including complete responses in 15 percent of patients. More than half of those who responded — 56 percent — were still responding after six months, according to the FDA.

The drug is the first dual-targeted therapy approved in this setting, Johnson & Johnson said. It targets two proteins that drive tumor growth, EGFR and MET, at the same time.

The approval does not cover everyone with head and neck cancer. It excludes patients with HPV-associated oropharyngeal squamous cell carcinoma, as determined by p16 testing, the FDA said.

Because the approval is accelerated, it is based on response rates and how long those responses lasted, rather than on longer-term survival data. Continued approval may depend on confirmation of benefit in the ongoing Phase 3 OrigAMI-5 trial, which is testing the drug in combination with carboplatin and pembrolizumab as a first-line treatment, according to the FDA and Johnson & Johnson.

The FDA granted the drug breakthrough therapy designation in February 2026 and priority review in July 2026. The review was conducted under Project Orbis, the FDA Oncology Center of Excellence initiative that coordinates cancer-drug reviews with regulators in other countries.

Sources: U.S. Food and Drug Administration, “FDA grants accelerated approval to amivantamab and hyaluronidase-lpuj for recurrent or metastatic head and neck squamous cell carcinoma” (Nov. 5, 2026); Johnson & Johnson, “Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer” (Nov. 5, 2026); Targeted Oncology, “FDA Approves Amivantamab and Hyaluronidase for Recurrent/Metastatic HNSCC” (Nov. 5, 2026).