European Commission Approves Subcutaneous RYBREVANT® (amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced that the European Commission has approved the subcutaneous formulation of RYBREVANT® (amivantamab), co-formulated with their ENHANZE® drug delivery technology. The approval covers two key indications:

• First-line treatment for advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations, in combination with LAZCLUZE®
• Monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure

The approval is backed by Phase 3 PALOMA-3 study results, demonstrating reduced administration time and decreased infusion-related reactions. This marks Halozyme's tenth approved partner product utilizing their ENHANZE® technology.

Positive

• European Commission approval expands market access for ENHANZE® technology
• Tenth approved partner product milestone achieved
• Clinical benefits demonstrated: reduced administration time and fewer infusion reactions

Negative

• None.

Insights

Biotechnology Analyst

The European Commission's approval of subcutaneous RYBREVANT® co-formulated with Halozyme's ENHANZE® technology represents a significant commercial milestone for Halozyme. This marks their tenth approved partner product utilizing the ENHANZE® platform, further validating their business model built around improving drug delivery through their proprietary technology.

The approval for treatment of EGFR-mutated non-small cell lung cancer carries substantial importance as NSCLC represents approximately 85% of all lung cancers. The PALOMA-3 clinical data demonstrated two critical advantages that differentiate subcutaneous administration: reduced administration time and decreased infusion-related reactions. These benefits create compelling value propositions for patients, healthcare providers, and payers.

For Halozyme's business model, each regulatory approval typically triggers milestone payments and establishes ongoing royalty streams from commercial sales. While specific financial terms weren't disclosed, this approval likely strengthens Halozyme's recurring revenue foundation through their partnership with Johnson & Johnson's Janssen unit.

This regulatory win continues to demonstrate Halozyme's execution in their platform technology strategy, where a single proprietary technology (ENHANZE®) can be leveraged across multiple partner products, creating an expanding portfolio of revenue-generating assets with favorable economics and diversified risk.

SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT^® (amivantamab), in combination with LAZCLUZE^® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. Additionally, it is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy.

Subcutaneous amivantamab is co-formulated Halozyme's ENHANZE^® drug delivery technology.

"We are delighted to announce the European approval of the subcutaneous formulation of amivantamab, developed using our innovative ENHANZE drug delivery technology. This marks our tenth approved partner product," said Dr. Helen Torley, President and CEO of Halozyme. "The data supporting this approval showed a reduced administration time and decrease in infusion-related reactions, which could have a positive impact on the healthcare system."

The EC approval is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For detailed information on the study and its findings, please refer to Johnson & Johnson's press release issued today.¹

¹ Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.

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 is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE^® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.

Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex^® and XYOSTED^®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. 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 infusion related reactions and broadening the treatment options for the indications referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme's ENHANZE^® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release. 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 uncertainties concerning whether the extension of marketing authorization for the subcutaneous formulation referred to in this press release is ultimately approved, 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
tbui@halozyme.com

Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What are the approved indications for subcutaneous RYBREVANT® in Europe?

It's approved for first-line treatment of advanced NSCLC with specific EGFR mutations in combination with LAZCLUZE®, and as monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.

What benefits does the subcutaneous formulation of RYBREVANT® with ENHANZE® technology offer?

The formulation demonstrates reduced administration time and decreased infusion-related reactions, potentially benefiting the healthcare system.

How many partner products has Halozyme (HALO) now approved with ENHANZE® technology?

This approval marks Halozyme's tenth approved partner product using their ENHANZE® drug delivery technology.

Which clinical trial supported the European approval of subcutaneous RYBREVANT®?

The Phase 3 PALOMA-3 study (NCT05388669) provided the supporting data for the European Commission approval.