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U.S. FDA Grants Approval for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

In a significant breakthrough for cancer treatment, the U.S. Food and Drug Administration (FDA) has given the green light to RYBREVANT FASPRO™, a co-formulated treatment by Halozyme Therapeutics, Inc. and Johnson & Johnson. This new therapy is intended for patients suffering from advanced epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), a condition that presents a considerable challenge to patients and healthcare providers alike.

Key Features of RYBREVANT FASPRO™

RYBREVANT FASPRO™ combines amivantamab with hyaluronidase-lpuj and is notable for being the first subcutaneous (SC) administered therapy targeting this particular type of cancer. This innovative product is derived from the established RYBREVANT® (amivantamab-vmjw), yet brings significant improvements in terms of administration efficiency.

Prior to this approval, patients typically received cancer treatments via intravenous (IV) routes, which could take several hours and be accompanied by various administration-related reactions. The introduction of RYBREVANT FASPRO™ radically cuts this time down to approximately five minutes, leading to an impressive fivefold reduction in associated reactions—13% for SC compared to 66% for IV treatments.

Dr. Helen Torley's Vision

Dr. Helen Torley, CEO of Halozyme, emphasized the advantages of using the ENHANZE® drug delivery technology that this new treatment employs. According to Dr. Torley, the streamlined administration not only provides convenience to patients and their families but also allows healthcare providers to manage schedules more efficiently, potentially lowering overall costs for the healthcare system.

The approval of RYBREVANT FASPRO™ is clearly a stride forward, as it symbolizes the enduring potential of ENHANZE technology to provide substantial clinical and economic benefits for patients and healthcare stakeholders.

Clinical Study Insights

The effectiveness and safety of RYBREVANT FASPRO™ stem from findings in the Phase 3 PALOMA-3 study. This study demonstrated that the new formulation consistently met essential pharmacokinetic endpoints, matching the results achieved with traditional RYBREVANT® treatments.

Halozyme and Future Directions

Halozyme is not resting on its laurels; the company is known for its commitment to improving patient outcomes and experiences through innovative therapies. Apart from RYBREVANT FASPRO™, Halozyme is diligently working on another advanced technology known as Hypercon™, aimed at enabling hyper-concentration of drugs. This innovative microparticle technology is expected to set a new standard by allowing reduced injection volumes, which can expand at-home treatment options.

In summary, the FDA’s approval of RYBREVANT FASPRO™ marks a pivotal moment in the fight against advanced NSCLC. It not only enhances the treatment landscape but also reflects Halozyme’s mission to innovate and improve patient care.

For further details regarding this approval, you can refer to the official press release issued by Johnson & Johnson on December 17, 2025.

For ongoing updates, connect with Halozyme Therapeutics through their official channels.