On Thursday, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Johnson & Johnson's (NYSE:JNJ) Rybrevant Faspro as a single agent for adults battling recurrent or metastatic head and neck squamous cell carcinoma (HCSCC).
Eligible patients include those whose cancer progressed during or following platinum-based chemotherapy and an anti-PD-(L)1 antibody. The label excludes HPV-associated oropharyngeal squamous cell carcinoma.
This is the first approval in 10 years of a drug for patients with recurrent or metastatic HNSCC who had received prior platinum-based chemotherapy.
Expanding Beyond Lung Cancer
The milestone represents the treatment's first approved indication outside non-small cell lung cancer.
The therapy targets both EGFR and MET pathways simultaneously while activating immune-cell directing activity, delivered via a five-minute subcutaneous injection.
Both receptors act as key drivers of tumor growth, overexpressed in 80% to 90% of recurrent and metastatic tumors.
The clearance follows the agency's Priority Review designation in July 2026 and an earlier Breakthrough Therapy Designation in February 2026.
Pivotal OrigAMI-4 Trial Results
Regulators based the decision on Cohort 1 of the Phase 1b/2 OrigAMI-4 trial, which investigators presented at the 2026 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
Among 102 evaluable participants, the therapy produced a confirmed 42% overall response rate. Complete responses occurred in 15% of patients-representing one-third of responders-while 28% achieved partial responses.
Additionally, 56% of responders maintained their response for more than six months. Continued approval remains contingent upon clinical verification in the ongoing Phase 3 OrigAMI-5 trial.
JNJ Price Action: Johnson & Johnson shares were up 0.25% at $272.99 at the time of publication on Friday. The stock is approaching its 52-week high of $282.01, according to Benzinga Pro data.