FDA Approves RYBREVANT FASPRO Co-Formulated with Halozyme's ENHANZE for Advanced EGFR-Mutated NSCLC

Reuters12-18

FDA Approves RYBREVANT FASPRO Co-Formulated with Halozyme's ENHANZE for Advanced EGFR-Mutated NSCLC

Halozyme Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), co-formulated with Halozyme's ENHANZE® drug delivery technology, for the treatment of patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). This approval was granted to Johnson & Johnson and covers all current indications for RYBREVANT® (amivantamab-vmjw). RYBREVANT FASPRO™ is notable for being the first and only subcutaneous targeted therapy for EGFR+ metastatic NSCLC, offering significantly reduced administration times and lower rates of administration-related reactions compared to intravenous delivery.

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. Halozyme Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA50521) on December 18, 2025, and is solely responsible for the information contained therein.

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