The U.S. Food and Drug Administration granted accelerated approval Thursday to Johnson & Johnson’s Rybrevant Faspro for certain adults with recurrent or metastatic head and neck cancer whose disease progressed after chemotherapy and immunotherapy.
The November 5 decision adds a treatment option for patients with head and neck squamous cell carcinoma after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication excludes HPV-associated oropharyngeal squamous cell carcinoma.
Approval rests on tumor responses
The FDA based its decision on an open-label, multicenter trial of 102 patients. The overall response rate was 42%, meaning tumors shrank or disappeared in that share of participants. Among patients who responded, 56% maintained a response for six months or longer.
The accelerated approval is based on the response rate and its duration. The FDA said it has not yet been confirmed whether those results translate into clinically meaningful long-term benefit, and it requires confirmatory studies.
For patients and families, the decision expands the available options after earlier treatment has stopped controlling the disease.
A subcutaneous treatment with safety risks
Rybrevant Faspro combines amivantamab and hyaluronidase-lpuj and is administered under the skin. Amivantamab targets the EGFR and MET pathways. Johnson & Johnson said the decision is the product’s first indication outside lung cancer.
In its announcement, the company reported serious adverse reactions in 39% of patients and fatal adverse reactions in 6% in the approval-supporting trial. Common reactions included rash, fatigue, nail toxicity, mouth inflammation and swelling.
The FDA lists warnings for hypersensitivity and administration-related reactions, lung inflammation, skin reactions, eye toxicity and harm to an unborn baby.
Confirmatory study continues
Johnson & Johnson identified the ongoing Phase 3 OrigAMI-5 study as the confirmatory trial. That study evaluates subcutaneous amivantamab with carboplatin and pembrolizumab as first-line treatment, a different regimen and treatment setting from the newly approved single-agent use.
Continued approval for the new indication may depend on verification of clinical benefit. The FDA granted the approval to Janssen Biotech, a Johnson & Johnson company.
JBizNews Desk | Washington
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