European Commission Approved Subcutaneous DARZALEX® (daratumumab)-based Quadruplet Regimen for the Treatment of Patients with Newly Diagnosed Multiple Myeloma, Regardless of Transplant Eligibility
Halozyme Therapeutics (NASDAQ: HALO) announced that the European Commission (EC) has approved an indication extension for DARZALEX® (daratumumab) subcutaneous (SC), which is co-formulated with Halozyme's ENHANZE® technology. The approval covers the use of daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for treating adult patients with newly diagnosed multiple myeloma.
This approval follows a previous indication extension in October 2024 for transplant-eligible patients, based on the Phase 3 PERSEUS study. The subcutaneous formulation eliminates the need for lengthy IV infusions, offering a more convenient treatment option for newly diagnosed multiple myeloma patients.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che la Commissione Europea (CE) ha approvato un'estensione dell'indicazione per DARZALEX® (daratumumab) sottocutaneo (SC), co-formulato con la tecnologia ENHANZE® di Halozyme. L'approvazione riguarda l'uso di daratumumab SC in combinazione con bortezomib, lenalidomide e desametasone (daratumumab-VRd) per il trattamento di pazienti adulti con mieloma multiplo recentemente diagnosticato.
Questa approvazione segue un'estensione dell'indicazione precedente nell'ottobre 2024 per i pazienti idonei al trapianto, basata sullo studio di Fase 3 PERSEUS. La formulazione sottocutanea elimina la necessità di lunghe infusioni endovenose, offrendo un'opzione di trattamento più comoda per i pazienti con mieloma multiplo recentemente diagnosticato.
Halozyme Therapeutics (NASDAQ: HALO) anunció que la Comisión Europea (CE) ha aprobado una extensión de indicación para DARZALEX® (daratumumab) subcutáneo (SC), que está co-formulado con la tecnología ENHANZE® de Halozyme. La aprobación cubre el uso de daratumumab SC en combinación con bortezomib, lenalidomida y dexametasona (daratumumab-VRd) para el tratamiento de pacientes adultos con mieloma múltiple recién diagnosticado.
Esta aprobación sigue a una extensión de indicación anterior en octubre de 2024 para pacientes elegibles para trasplante, basada en el estudio de Fase 3 PERSEUS. La formulación subcutánea elimina la necesidad de largas infusiones intravenosas, ofreciendo una opción de tratamiento más conveniente para los pacientes con mieloma múltiple recién diagnosticado.
Halozyme Therapeutics (NASDAQ: HALO)는 유럽연합 집행위원회(EC)가 DARZALEX® (다라투무맙) 피하주사(SC)의 적응증 연장을 승인했다고 발표했습니다. 이 약물은 Halozyme의 ENHANZE® 기술과 함께 공동 조제되었습니다. 이 승인은 다라투무맙 SC를 보르테조밉, 레날리도미드 및 덱사메타손(다라투무맙-VRd)과 함께 사용하여 새로 진단된 성인 다발성 골수종 환자를 치료하는 것을 포함합니다.
이번 승인은 2024년 10월에 이식이 가능한 환자에 대한 이전 적응증 연장에 이어 나온 것으로, 3상 PERSEUS 연구를 기반으로 합니다. 피하 제형은 긴 IV 주입의 필요성을 없애주며, 새로 진단된 다발성 골수종 환자에게 더 편리한 치료 옵션을 제공합니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé que la Commission Européenne (CE) a approuvé une extension d'indication pour DARZALEX® (daratumumab) sous-cutané (SC), qui est co-formulé avec la technologie ENHANZE® de Halozyme. L'approbation concerne l'utilisation de daratumumab SC en combinaison avec le bortezomib, la lénaalidomide et la dexaméthasone (daratumumab-VRd) pour traiter les patients adultes nouvellement diagnostiqués avec un myélome multiple.
Cette approbation fait suite à une précédente extension d'indication en octobre 2024 pour les patients éligibles à la transplantation, basée sur l'étude de Phase 3 PERSEUS. La formulation sous-cutanée élimine le besoin de longues perfusions IV, offrant une option de traitement plus pratique pour les patients nouvellement diagnostiqués avec un myélome multiple.
Halozyme Therapeutics (NASDAQ: HALO) gab bekannt, dass die Europäische Kommission (EK) eine Erweiterung der Indikation für DARZALEX® (Daratumumab) subkutan (SC) genehmigt hat, das in Kombination mit Halozymes ENHANZE®-Technologie formuliert ist. Die Genehmigung umfasst die Anwendung von Daratumumab SC in Kombination mit Bortezomib, Lenalidomid und Dexamethason (Daratumumab-VRd) zur Behandlung von Erwachsenen mit neu diagnostiziertem multiplem Myelom.
Diese Genehmigung folgt auf eine frühere Indikationserweiterung im Oktober 2024 für transplantationsfähige Patienten, die auf der Phase-3-Studie PERSEUS basiert. Die subkutane Formulierung beseitigt die Notwendigkeit langer IV-Infusionen und bietet eine bequemere Behandlungsoption für neu diagnostizierte Patienten mit multiplem Myelom.
- EC approval expands market access for HALO's ENHANZE technology in multiple myeloma treatment
- Broader patient population access through indication extension to both transplant-eligible and non-eligible patients
- Partnership with major pharmaceutical company Johnson & Johnson strengthens market position
- None.
Insights
The European Commission's approval for DARZALEX® subcutaneous (daratumumab SC) in combination with VRd represents a significant commercial catalyst for Halozyme. This regulatory milestone expands the addressable market for Halozyme's ENHANZE® drug delivery technology to include newly diagnosed multiple myeloma patients regardless of transplant eligibility.
This approval carries substantial revenue implications for Halozyme through their partnership with Janssen (J&J). The subcutaneous formulation enabled by ENHANZE® technology delivers meaningful clinical benefits by eliminating lengthy IV infusions – a significant advantage for this patient population. The inclusion in first-line treatment regimens positions ENHANZE®-enabled daratumumab as a foundational therapy across the treatment spectrum.
Multiple myeloma's treatment paradigm increasingly involves combination therapies administered over extended periods. The quadruplet regimen approved here (daratumumab-VRd) represents the cutting edge of treatment intensity, with each additional approved indication expanding Halozyme's royalty-generating opportunities. This follows the transplant-eligible indication secured in October 2024, completing coverage across the newly diagnosed patient spectrum.
This approval further validates Halozyme's drug delivery platform technology business model, which generates high-margin, recurring revenue streams through partnerships with major pharmaceutical companies. The continued regulatory success of ENHANZE®-enabled products strengthens Halozyme's position as the dominant subcutaneous delivery technology provider in oncology.
Subcutaneous DARZALEX® is co-formulated with Halozyme's ENHANZE® drug delivery technology
"The continued expansion of DARZALEX delivered subcutaneously with ENHANZE into additional settings highlights its status as a cornerstone of therapy for multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions."
This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant, based on the results from the Phase 3 PERSEUS (NCT03652064) study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance.2,3
1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025.
2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.
3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-sc-based-quadruplet-regimen-approved-by-the-european-commission-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible. Last accessed: April 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 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
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
Samantha Gaspar
Teneo
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SOURCE Halozyme Therapeutics, Inc.
FAQ
What is the new European Commission approval for DARZALEX SC with HALO's ENHANZE technology?
How does the DARZALEX SC formulation benefit multiple myeloma patients compared to IV administration?
When was the previous indication extension for DARZALEX SC approved for transplant-eligible patients?
What clinical trial supported the approval of DARZALEX SC for newly diagnosed multiple myeloma?
