42% Response Rate Drives US Accelerated Approval for Advanced Head and Neck Cancer Treatment
Key Facts
On November 5, the US 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 whose disease progressed during or after platinum-based chemotherapy or immunotherapy. The agency said the approval was granted to Janssen Biotech, a Johnson & Johnson subsidiary, identifying the company that received the authorization. The decision was based on an overall response rate of 42% in a trial involving 102 patients. Among patients who responded to treatment, responses lasted 6 months or longer in 56%. The FDA described it as the first drug approved for this type of patient in 10 years.
The agency compared the response rate with currently approved treatments for the condition, saying they are associated with an overall response rate of about 20% or less. This means the drug’s pivotal-trial result was higher than the rate the agency cited for available treatments, according to the comparison in its approval announcement. In its efficacy summary, the FDA estimated the 42% response rate within a 95% confidence interval of 32% to 52%. It also said 56% of responders maintained their response for at least 6 months. The primary efficacy population included 102 patients and excluded patients with HPV-associated oropharyngeal cancer based on «p16» test results.
The authorization was granted under the accelerated approval pathway, based on the response rate and its duration. The FDA said continued approval may depend on confirmatory studies that verify and describe clinical benefit. Confirmation of clinical benefit therefore remains among the regulatory requirements associated with the decision, alongside the response data underlying the initial authorization. The drug application received priority review, and amivantamab and hyaluronidase-lpuj received breakthrough therapy designation. These reflect the review pathway and designations listed by the agency in its approval record.
In the trial described by the FDA, patients received amivantamab and hyaluronidase-lpuj alone, at a weight-based dose, by subcutaneous injection every 3 weeks. Treatment continued until disease progression or unacceptable toxicity. These details place the drug’s administration schedule among the published trial data, alongside the response rate and duration. On follow-up, Johnson & Johnson said the Phase 3 OrigAMI-5 study is evaluating subcutaneous amivantamab with carboplatin and pembrolizumab as a first-line treatment. The study targets patients with recurrent or metastatic head and neck cancer, in the context of confirmatory studies related to the treatment.
Genmab’s published interim report showed revenue of $3.238 billion in the first 9 months of 2026, compared with $2.662 billion in the same period of 2025, an increase of 22%. Royalty revenue rose 22% over the same period to $2.699 billion from $2.219 billion. Third-quarter revenue was $1.187 billion, up 16% from $1.022 billion in the same quarter of 2025. In its disclosure, Genmab said Janssen is responsible for developing and commercializing amivantamab, and that it receives royalties ranging from 8% to 10% of Rybrevant net sales, subject to the reductions described by the company. This places Genmab on the royalty side of the drug’s economics, while the US approval was granted to Janssen Biotech.
On its financial outlook, Genmab said in its report issued on November 5 that it maintained its 2026 financial guidance published on August 6. The drug’s regulatory path remains tied to the confirmatory studies the FDA said may be required for continued accelerated approval. The OrigAMI-5 study is testing a different treatment combination from the monotherapy described in the trial data on which the authorization was based. According to Johnson & Johnson, the study combines subcutaneous amivantamab with carboplatin and pembrolizumab as a first-line treatment. The study concerns patients with recurrent or metastatic head and neck cancer.