TLDR
JNJ shares gain 0.35% as FDA approval adds a new head and neck cancer treatment.
RYBREVANT FASPRO targets EGFR and MET in certain advanced head and neck cancers.
The FDA approval excludes HPV-associated oropharyngeal squamous cell carcinoma.
OrigAMI-4 trial reports a 42% response rate across 102 previously treated patients.
FDA approval expands JNJ’s oncology portfolio, backed by a 42% trial response rate.
Johnson & Johnson (JNJ) stock climbed 0.35% to $273.27 after the FDA approved RYBREVANT FASPRO for certain advanced head and neck cancers. Shares gained $0.95 after recovering from intraday lows near $266.50. The approval expands the company’s oncology portfolio but excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.
Johnson & Johnson, JNJ
FDA Approves RYBREVANT FASPRO With HPV-Related Exclusion
The FDA granted accelerated approval for RYBREVANT FASPRO to treat adults with recurrent or metastatic head and neck cancer. Eligible patients must have experienced disease progression after platinum-based chemotherapy and anti-PD-(L)1 treatment. The indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma, identified through p16 immunohistochemistry testing.
The HPV exclusion specifically applies to oropharyngeal tumors associated with the virus. Meanwhile, the therapy targets EGFR and MET, two pathways involved in cancer growth and progression. Johnson & Johnson administers the treatment through a subcutaneous injection that takes approximately five minutes.
The FDA granted Breakthrough Therapy Designation in February 2026 and Priority Review in July 2026. Moreover, the decision marks RYBREVANT FASPRO’s first approved indication beyond non-small cell lung cancer. The approval expands available treatment options for eligible patients whose disease progresses after earlier therapies.
OrigAMI-4 Trial Reports 42% Response Rate
The FDA based its decision on findings from the ongoing Phase 1b/2 OrigAMI-4 clinical trial. Researchers evaluated 102 patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma. Importantly, the study excluded patients with HPV-positive oropharyngeal squamous cell carcinoma.
The trial recorded a confirmed overall response rate of 42%, including complete responses in 15% of patients. Additionally, 28% achieved partial responses, while 56% of responders maintained benefits beyond six months. These findings supported accelerated approval based on measurable and durable tumor responses.
Researchers identified adverse reactions, including rash, fatigue, nail toxicity, stomatitis, and edema. Serious adverse reactions affected 39% of patients, while fatal adverse reactions occurred in 6%. Meanwhile, the ongoing Phase 3 OrigAMI-5 trial will evaluate clinical benefits to support continued approval.
FDA Decision Expands Johnson & Johnson’s Oncology Portfolio
The latest regulatory decision strengthens Johnson & Johnson’s position in advanced cancer treatment. Furthermore, RYBREVANT FASPRO introduces dual EGFR and MET targeting for eligible patients with limited treatment alternatives. The therapy also extends the company’s existing amivantamab franchise into another cancer category.
Head and neck squamous cell carcinoma affects tissues lining the mouth, throat, and other nearby structures. Advanced cases often present treatment challenges after patients undergo chemotherapy and immunotherapy. Consequently, the new indication addresses a specific group of patients whose disease progresses despite previous treatment.
The stock’s intraday recovery reflected renewed buying activity following earlier selling pressure. The FDA decision adds another regulatory milestone to the company’s broader oncology development strategy. Johnson & Johnson will continue evaluating RYBREVANT FASPRO through clinical trials as it expands its cancer treatment portfolio.
The post Johnson & Johnson (JNJ) Stock: Rises to $273 as FDA Approves RYBREVANT FASPRO for Head and Neck Cancer appeared first on Blockonomi .
