1. FDA approves RYBREVANT FASPRO™ for EGFR-mutated lung cancer. 2. RYBREVANT FASPRO™ is the first subcutaneous therapy for EGFR+ NSCLC. 3. The approval reduces administration time from hours to about five minutes. 4. ENHANZE® technology improves patient experience and may lower healthcare costs. 5. Halozyme's Hypercon™ technology extension further broadens drug delivery options.
FAQ
Why Bullish?
The FDA approval for RYBREVANT FASPRO™ validates Halozyme's ENHANZE technology, potentially enhancing revenue from new therapies.
How important is it?
The article highlights FDA approval of a significant product leveraging Halozyme's technology, crucial for future growth.
Why Long Term?
Successful integration of ENHANZE technology in new drugs may contribute to sustained growth, similar to prior successful launches.
FDA Approves RYBREVANT FASPRO™ for Advanced Lung Cancer Treatment
Halozyme Therapeutics, Inc. (NASDAQ: HALO) has announced a significant milestone in cancer treatment as Johnson & Johnson obtains U.S. Food and Drug Administration (FDA) approval for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj). This innovative therapy, co-formulated with ENHANZE®, is designed for patients suffering from epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).
Key Benefits of RYBREVANT FASPRO™
RYBREVANT FASPRO™ is groundbreaking as it delivers the first and only subcutaneous (SC) administration of targeted therapy for EGFR+ mNSCLC.
- Faster Administration: The SC delivery method reduces treatment time from several hours to approximately five minutes.
- Fewer Reactions: Studies indicate a fivefold decrease in administration-related reactions (ARRs)—13% for SC versus 66% for traditional intravenous (IV) methods.
Comments from Halozyme Leadership
Dr. Helen Torley, President and CEO of Halozyme, emphasized the importance of this approval, stating, "Formulated with our leading ENHANZE drug delivery technology, RYBREVANT FASPRO™ has the potential to make administration faster and more convenient for patients and their families." She highlighted how ENHANZE can enhance both patient experience and healthcare efficiency while potentially lowering overall costs.
Clinical Study Outcomes and Regulatory Context
The FDA's approval was based on findings from the Phase 3 PALOMA-3 study (NCT05388669), where RYBREVANT FASPRO™ met both co-primary pharmacokinetic (PK) endpoints. Specifically, it achieved the required amivantamab levels in the bloodstream, thereby confirming its efficacy.
For further details regarding the approval, you can refer to Johnson & Johnson's press release dated December 17, 2025.
About Halozyme and ENHANZE® Technology
Halozyme is a pioneer in biopharmaceutical solutions, dedicated to enhancing patient experiences and treatment outcomes. Its patented ENHANZE® drug delivery technology, utilizing the proprietary enzyme rHuPH20, enables subcutaneous delivery of various therapeutic drugs.
- ENHANZE® has positively impacted over one million patients across more than 100 global markets.
- Licensing partnerships include leading pharmaceuticals like Roche, Takeda, Pfizer, and AbbVie.
Forward-Looking Statements
Halozyme's future strategy includes the development of Hypercon™, a microparticle technology intended to further enhance drug delivery capabilities. This innovation aims to reduce injection volumes while maximizing therapeutic effectiveness.
The company holds promising prospects for both existing and new therapeutic solutions, ensuring continued improvement in patient care within the oncology sphere.