Johnson & Johnson said the U.S. FDA granted Breakthrough Therapy Designation to RYBREVANT FASPRO (subcutaneous amivantamab and hyaluronidase-lpuj) as monotherapy for adults with recurrent or metastatic, HPV-unrelated head and neck squamous cell carcinoma after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The designation is supported by data from the open-label Phase 1b/2 OrigAMI-4 study; results were already presented at the 2025 ESMO Congress. The company said the subcutaneous formulation is also being further evaluated in the ongoing Phase 3 OrigAMI-5 study in first-line HPV-unrelated recurrent or metastatic HNSCC.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief via PR Newswire (Ref. ID: 202602180730PR_NEWS_USPR_____NY90064) on February 18, 2026, and is solely responsible for the information contained therein.