FDA Approved DARZALEX Faspro® for Adult Patients with High-Risk Smoldering Multiple Myeloma

Rhea-AI Summary

Halozyme (NASDAQ: HALO) announced on November 7, 2025 that Johnson & Johnson received FDA approval of DARZALEX Faspro (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE as a single-agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro is described as the first and only approved treatment for HR-SMM, enabling earlier intervention before progression to active multiple myeloma.

The approval was based on the Phase 3 AQUILA study (NCT03301220) comparing DARZALEX Faspro to active monitoring. The release notes ~36,000 estimated U.S. multiple myeloma diagnoses in 2025, ~15% classified as smoldering, and an estimated 50% of HR-SMM patients progress within two years.

Positive

• FDA approval for HR-SMM indication (Nov 7, 2025)
• First and only approved treatment for HR-SMM
• Approval supported by Phase 3 AQUILA trial (NCT03301220)
• Co-formulated with ENHANZE drug delivery technology

Negative

• Approval applies only to adult HR-SMM patients

Insights

Clinical/Commercial Biotech Strategist

FDA approved DARZALEX Faspro for high‑risk smoldering multiple myeloma, creating the first approved early‑intervention therapy.

As a co‑formulation with Halozyme's ENHANZE delivery technology, DARZALEX Faspro now holds a new FDA indication dated Nov. 7, 2025 for single‑agent treatment of adult patients with high‑risk smoldering multiple myeloma (HR‑SMM). This approval establishes a regulatory pathway for earlier therapeutic intervention in a population previously managed by active monitoring, and it formally positions the product as the first approved treatment option for HR‑SMM.

Key dependencies and risks include commercial execution by the marketing author (Johnson & Johnson), real‑world adoption versus historical "watch and wait" practice, and the details and strength of the supporting evidence from the AQUILA Phase 3 trial. The release notes that roughly 15% of the estimated 36,000 annual U.S. multiple myeloma diagnoses are smoldering, and that about 50% of HR‑SMM patients may progress within two years, which frames both the target population size and the clinical urgency that supports uptake.

Watch for the full AQUILA data and Johnson & Johnson's commercialization plans as immediate next items; the company’s press release dated Nov. 6, 2025 is cited for study details. Near‑term (months) signals to monitor include labeling specifics, reimbursement decisions, and guideline updates; medium‑term (within two years) signals include real‑world uptake and observed impact on progression rates in treated HR‑SMM cohorts.

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

SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

"DARZALEX Faspro is the first approved treatment in the U.S. for adult patients with high risk smoldering multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "The approval expands the indications for DARZALEX Faspro with ENHANZE, further solidifying its role as a cornerstone therapy across all stages of multiple myeloma."  

Smoldering multiple myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow.^1,2,3 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S., and approximately 15 percent of those are classified as smoldering.^4,5 An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis.⁵ Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.⁵

The FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX Faspro® compared to active monitoring (or "Watch and Wait") in the largest Phase 3 trial in patients with HR-SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on November 6, 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

¹ American Cancer Society. What is Multiple Myeloma? Accessed June 2025. Available at: https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html
² Oben, B, Froyen, G, Maclachlan, K.H, et al. Whole-genome sequencing reveals progressive versus stable myeloma precursor conditions as two distinct entities. Nat Commun 2021;12(1861). doi:10.1038/s41467-021-22140-0
³ Maura, F, Bergsagel PL. Targeting the Tumor and the Immune System in Smoldering Multiple Myeloma. N Engl J Med. 2025;392:1858-1860. doi: 10.1056/NEJMe2504273
⁴ American Cancer Society. Myeloma Cancer Statistics. Accessed June 2025. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html
⁵ M.A. Dimopoulos, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Presented at the December 2024 ASH Annual Meeting & Exposition. Abstract JJD-78127.

 

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SOURCE Halozyme Therapeutics, Inc.

FAQ

What did Halozyme announce about DARZALEX Faspro on November 7, 2025 (HALO)?

Halozyme said Johnson & Johnson received FDA approval for DARZALEX Faspro for adult patients with high-risk smoldering multiple myeloma.

Why is the DARZALEX Faspro FDA approval significant for HR-SMM (HALO)?

DARZALEX Faspro is described as the first and only approved treatment for HR-SMM, enabling earlier intervention before progression to active disease.

What study supported the FDA approval of DARZALEX Faspro (HALO)?

The approval was based on findings from the Phase 3 AQUILA study (NCT03301220) comparing DARZALEX Faspro to active monitoring.

How common is smoldering multiple myeloma according to the November 7, 2025 release (HALO)?

The release cites an estimate that ~36,000 people will be diagnosed with multiple myeloma in the U.S. in 2025 and ~15% are classified as smoldering.

What is the near-term clinical risk for patients with HR-SMM cited in the announcement (HALO)?

The announcement states an estimated 50% of HR-SMM patients are likely to progress to active disease within two years of diagnosis.

What role does Halozyme have with DARZALEX Faspro and ENHANZE (HALO)?

DARZALEX Faspro is co-formulated with Halozyme's ENHANZE drug delivery technology, as noted in the announcement.