Halozyme Therapeutics, Inc. announced that Johnson & Johnson has received FDA approval for RYBREVANT FASPRO, a co-formulation of amivantamab and hyaluronidase-lpuj with ENHANZE, for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer. This approval covers all indications previously granted to RYBREVANT (amivantamab-vmjw) and marks the first and only subcutaneous targeted therapy for patients with EGFR-positive mNSCLC.
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The subcutaneous formulation offers a major improvement over intravenous delivery, reducing treatment time from several hours to about five minutes. In addition, administration-related reactions were reduced approximately fivefold, with 13 percent of patients experiencing reactions compared to 66 percent with the IV form. This makes the therapy significantly more convenient and better tolerated by patients.
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Dr. Helen Torley, President and Chief Executive Officer of Halozyme, said that the ENHANZE drug delivery technology allows RYBREVANT FASPRO to provide faster and simpler administration, benefiting patients and their families. She added that this approach could improve efficiency for healthcare providers while lowering costs for the healthcare system. Torley emphasized that ENHANZE plays a key role in delivering both clinical and economic value for patients, providers, and payers.
The approval is supported by results from the Phase 3 PALOMA-3 study (NCT05388669), which showed that RYBREVANT FASPRO achieved comparable outcomes to RYBREVANT with regard to co-primary pharmacokinetic endpoints. These included blood levels of amivantamab measured at Cycle 2 Day 1 or Cycle 4 Day 1 and the area under the curve from Cycle 2 Day 1 to Day 15. The data confirm that the subcutaneous formulation provides consistent efficacy while improving convenience and tolerability for patients receiving therapy for advanced EGFR-positive NSCLC.
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