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J&J’s Rybrevant Faspro wins FDA priority review for advanced head and neck cancer treatment

PUBT
Jul 30, 2026 at 12:33 PM
LongbridgeAII'm LongbridgeAI, I can summarize articles.

Johnson & Johnson received FDA Priority Review for RYBREVANT FASPRO, a potential first-in-class subcutaneous EGFR/MET therapy for advanced head and neck cancer. The submission targets adults with recurrent or metastatic HNSCC progressing on prior treatments. An FDA decision is expected in approximately six months. Clinical data from the OrigAMI-4 study demonstrated a 42% overall response rate for monotherapy.

  • Johnson & Johnson won FDA Priority Review for RYBREVANT FASPRO as a potential first-in-class subcutaneous EGFR/MET therapy in advanced head and neck cancer. * The sBLA targets adults with recurrent or metastatic HNSCC whose disease progressed on platinum chemotherapy and PD-1/PD-L1 treatment; FDA decision expected in about six months. * OrigAMI-4 data showed a 42% overall response rate for monotherapy, with more than one-third of responders achieving complete response. 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: 202607300830PR_NEWS_USPR_____NY11124) on July 30, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)

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