European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma

Rhea-AI Summary

Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen-Cilag received European Commission approval for DARZALEX Faspro®, co-formulated with Halozyme's ENHANZE® technology, for treating high-risk smouldering multiple myeloma (SMM) in adult patients.

This approval marks a significant shift from the current "Watch and Wait" standard of care, enabling early intervention in SMM patients before disease progression. The approval is based on the Phase 3 AQUILA study evaluating fixed-duration monotherapy daratumumab SC versus active monitoring in high-risk SMM patients.

Positive

• First approved treatment for high-risk smouldering multiple myeloma, expanding DARZALEX Faspro market potential
• Validation of ENHANZE technology in another therapeutic application
• Addresses unmet medical need by enabling early intervention instead of 'watch and wait' approach

Negative

• None.

DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology

Approval represents critical advancement in early intervention for multiple myeloma

SAN DIEGO, July 23, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE®, as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma.

"This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease."

SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. The current standard of care for SMM, even in high-risk cases, is active monitoring (or "Watch and Wait") to track for signs of biochemical progression and/or end-organ damage. This means therapeutic intervention is only offered when the disease progresses.

The EC approval is supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on July 23, 2025.

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 ten commercialized products in at least one major region and 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 McDermott Laboratories Limited, an affiliate of Viatris Inc.

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 broadening the treatment options for the indications 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 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

Sydney Charlton
Teneo
917-972-8407
sydney.charlton@teneo.com

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What is the new European Commission approval for DARZALEX Faspro with HALO's ENHANZE technology?

The EC approved DARZALEX Faspro as a monotherapy treatment for adult patients with high-risk smouldering multiple myeloma (SMM), representing a shift from the traditional 'watch and wait' approach.

How does this approval impact Halozyme's (HALO) market position?

This approval strengthens HALO's position by validating ENHANZE technology in another application and expanding DARZALEX Faspro's market reach to earlier-stage multiple myeloma patients.

What clinical trial supported the EC approval of DARZALEX Faspro for SMM?

The approval was supported by the Phase 3 AQUILA study (NCT03301220), which evaluated the efficacy and safety of fixed-duration monotherapy daratumumab SC compared to active monitoring in high-risk SMM patients.

What is the current standard of care for smouldering multiple myeloma that DARZALEX Faspro will replace?

The current standard is active monitoring ('Watch and Wait') to track disease progression, whereas DARZALEX Faspro now enables therapeutic intervention before disease progression in high-risk cases.

What is smouldering multiple myeloma (SMM)?

SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow, representing a stage before full multiple myeloma development.