RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) - (OrigAMI–4)

July 30, 2026: Johnson & Johnson (NYSE: JNJ) said the FDA granted Priority Review to its supplemental BLA for subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease progressed after platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. Priority Review shortens the FDA review timeline to ~6 months (no specific action date stated).

The filing is supported by pivotal Phase 1b/2 OrigAMI-4 (NCT06385080) results: in the monotherapy cohort, 42% overall response rate, with more than one-third of responders achieving a complete response. The study excluded HPV-driven oropharyngeal SCC and patients with prior anti-EGFR therapy. Data were presented at the 2026 ASCO Annual Meeting and published simultaneously in the Journal of Clinical Oncology.

OrigAMI-4 is an open-label Phase 1b/2 study with six cohorts evaluating RYBREVANT FASPRO across different settings/regimens; the primary endpoint across cohorts is ORR per RECIST v1.1.