JNJ Rybrevant Faspro Priority Review for HNSCC

Johnson & Johnson (JNJ) announced on July 30 that the FDA granted Priority Review to the supplemental Biologics License Application for subcutaneous RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum chemotherapy and PD-1 or PD-L1 immunotherapy. Priority Review shortens the FDA timeline to approximately six months, putting the PDUFA in the first quarter of 2027.

The drug already received Breakthrough Therapy designation for this indication in February 2026. JNJ closed at $265.53 on July 29.

The OrigAMI-4 data

The sBLA is supported by the Phase 1b/2 OrigAMI-4 study (NCT06385080). In cohort 1, 102 patients received subcutaneous amivantamab monotherapy after prior platinum and checkpoint inhibitor treatment. The overall response rate was 42% (95% CI, 32% to 52%), with 15% achieving a complete response and a clinical benefit rate of 63%. At a median follow-up of 11.8 months, median progression-free survival was 6.8 months and median overall survival was 12.5 months.

The study excluded patients with HPV-positive oropharyngeal squamous cell carcinoma and those with prior anti-EGFR therapy, focusing on a heavily pretreated population with limited options.

Why the mechanism matters

Amivantamab is a bispecific antibody targeting both EGFR and MET, receptors overexpressed in 80 to 90% of HNSCC tumors and implicated in treatment resistance. It is the only therapy in HNSCC engineered to hit both targets simultaneously. The drug engages the immune system through its Fc domain, combining direct pathway inhibition with immune-mediated tumor killing.

RYBREVANT FASPRO was approved in December 2025 for EGFR-mutated non-small cell lung cancer, where it built adoption as a subcutaneous alternative to the IV formulation. Head and neck cancer is a different disease with different tumor biology, making this a genuine new indication rather than a label expansion.

The competitive picture

Post-platinum, post-IO head and neck cancer has a five-year survival rate of only 15%. Current options include Merck’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Erbitux (cetuximab), but neither targets MET and both have modest efficacy in this setting. The OrigAMI-4 data was presented at ASCO 2026 and published in the Journal of Clinical Oncology.

The risk: this is a single-arm Phase 1b/2 trial with ORR as the primary endpoint, not a randomized Phase 3 with overall survival. The FDA could require a confirmatory trial. For a primer on supplemental filings like this one, see our guide to sBLA and sNDA filings.

Source: JNJ press release | OrigAMI-4 on ClinicalTrials.gov