FDA Approval Opens New Treatment Option for Head and Neck Cancer After 42% Response Rate
Key Facts
On November 5, 2026, the U.S. Food and Drug Administration granted accelerated approval to RYBREVANT FASPRO, a combination of amivantamab and hyaluronidase-lpuj, to treat adults with recurrent or metastatic squamous cell carcinoma of the head and neck. The indication covers patients whose disease progressed during or after platinum-based chemotherapy, as well as during or after treatment with an anti-PD-(L)1 antibody. The approval gives a treatment option to this group, which has already received both treatments. According to the agency’s statement, this is the first FDA approval in ten years for a drug intended for patients with recurrent or metastatic disease of this cancer after platinum-based treatment. The company said the drug is the first bispecific-targeted treatment approved in this setting.
The efficacy assessment was based on OrigAMI-4, an open-label, multicenter study. The primary efficacy population included 102 patients previously treated with a platinum-based regimen and an anti-PD-(L)1 antibody. The objective response rate was 42%, with a 95% confidence interval of 32% to 52%. Among patients who responded to treatment, the response lasted at least six months in 56%. These results provide a measure of response and its duration in the studied population, which formed the basis for the accelerated approval decision.
Participants received amivantamab and hyaluronidase-lpuj as monotherapy by subcutaneous injection once every 3 weeks. The dosing regimen continued until disease progression or unacceptable toxicity, according to information provided by the FDA. This means the regimen used in the study was administered continuously at that interval, stopping when either event occurred. The approval applies to patients who meet the specified prior-treatment criteria and does not cover all cases of recurrent or metastatic head and neck cancer. Specifically, the drug is not indicated for HPV-associated oropharyngeal squamous cell carcinoma.
The FDA described its decision as an accelerated approval, a pathway tied to results for response rate and duration of response. These results have not yet been shown to translate into a meaningful clinical benefit in long-term outcomes, according to the agency. The FDA therefore required confirmatory studies to verify and characterize the clinical benefit. Those studies are the next required step after the drug’s availability under the decision. Confirmation of clinical benefit will determine the extent to which the initial results support approval over the longer term.
In trading on November 5, 2026, Johnson & Johnson shares closed at $272.32, according to EL7 data. The stock had closed at $276.32 on November 4, before closing lower the following day. This places the closing price on the session when the approval was announced in immediate context relative to the previous session. The available data do not include a reliable price for the stock’s high during the November 5 session. The FDA decision came on the same day the stock recorded this close.