U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer

RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw)

SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).¹ RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) and represents the first and only subcutaneously (SC) administered targeted therapy for patients with EGFR+ mNSCLC.

Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm).

"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," said Dr. Helen Torley, president and chief executive officer of Halozyme. "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 economical value for patients, providers and payers."

Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO™ delivered consistent results to RYBREVANT®, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [Ctrough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUCD1-D15)].^1,2

For more information on this approval, please view Johnson & Johnson's press release issued on December 17, 2025.

References

^1.RYBREVANT FASPRO™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

^2.Yang J et al. Amivantamab Plus Lazertinib vs Osimertinib in First-line EGFR-mutant Advanced NSCLC – Final Overall Survival from MARIPOSA [ELCC abstract #40]. Presented at: 2025 European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies.

As the innovators of ENHANZE^® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE^® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, and Merus N.V.

Halozyme is also developing Hypercon™ to expand the breadth of its drug delivery technology portfolio. Hypercon™ is an innovative microparticle technology that is expected to set a new standard in hyper concentration of drugs and biologics that can reduce the injection volume for the same dosage and expands opportunities for at-home and health care provider administration. The addition of Hypercon™ enhances our ability to transform the patient treatment experience by enabling the creation and delivery of highly concentrated biologics, substantially broadening the scope of therapeutics that can be delivered subcutaneously. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson, Eli Lilly, and argenx.

Halozyme also develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability, and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex^® and XYOSTED^®, partnered commercial products, and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.

For more information, visit www.halozyme.com and connect with us on LinkedIn and Twitter.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and administration-related reactions, broadening the treatment options for the indications referred to in this press release, support efficiencies for healthcare providers and potentially lower healthcare system costs. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contacts:

Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
[email protected]

Sydney Charlton
Teneo
917-972-8407
[email protected]

SOURCE Halozyme Therapeutics, Inc.