FDA approved RYBREVANT FASPRO on December 17, 2025, making it the first subcutaneous (SC) targeted therapy for patients with epidermal growth factor receptor (EGFR)‑mutated metastatic non‑small cell lung cancer (NSCLC). The approval follows a complete response letter issued in December 2024 that addressed manufacturing observations, underscoring Halozyme’s ability to resolve regulatory hurdles and bring a product to market.
RYBREVANT FASPRO is a subcutaneous formulation of amivantamab co‑formulated with Halozyme’s ENHANZE hyaluronidase enzyme. The ENHANZE platform disperses the biologic rapidly, cutting administration time from several hours to roughly five minutes and reducing administration‑related reactions (ARRs) from 66 % with intravenous delivery to 13 % with the SC formulation. These clinical benefits position the drug as a convenient alternative to the existing IV regimen and are expected to drive adoption by oncologists and patients alike.
The SC formulation is supported by data from the Phase 3 PALOMA‑3 trial, which demonstrated pharmacokinetic equivalence and comparable clinical outcomes between the SC and IV forms of amivantamab. In the MARIPOSA trial, RYBREVANT plus LAZCLUZE showed an overall survival benefit versus osimertinib, and the SC product is expected to maintain that benefit while offering greater convenience for patients and providers.
For Halozyme, the approval expands its royalty base by adding a new partner product that will generate mid‑single‑digit royalty revenue. The success of RYBREVANT FASPRO further validates the ENHANZE platform, reinforcing its value proposition in oncology and positioning Halozyme to attract additional partners in the growing SC biologics segment. The approval also strengthens Halozyme’s competitive stance by demonstrating the platform’s ability to convert IV biologics into patient‑friendly SC options.
Dr. Helen Torley, President and CEO of Halozyme, said, “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 compared to intravenous administration. By reducing administration times and simplifying the treatment experience, ENHANZE‑formulated products could also support efficiencies for healthcare providers and lower costs for the healthcare system. This approval underscores ENHANZE’s role in delivering meaningful clinical and economic value for patients, providers and payers.”
The approval follows a complete response letter issued in December 2024 that cited observations at a manufacturing facility during a pre‑approval inspection. The resolution of those concerns and the subsequent approval demonstrate Halozyme’s capacity to address regulatory challenges and bring its platform‑enabled products to market, further solidifying its position as a key partner for pharmaceutical companies seeking to improve drug delivery.
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