European Commission Approved DARZALEX Faspro庐 for Adult Patients with Smouldering Multiple Myeloma
Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen-Cilag received European Commission approval for DARZALEX Faspro庐, co-formulated with Halozyme's ENHANZE庐 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.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che Janssen-Cilag ha ottenuto l'approvazione dalla Commissione Europea per DARZALEX Faspro庐, co-formulato con la tecnologia ENHANZE庐 di Halozyme, per il trattamento del mieloma multiplo smouldering ad alto rischio (SMM) in pazienti adulti.
Questa approvazione rappresenta un cambiamento significativo rispetto all'attuale standard di cura "Osservazione e Attesa", permettendo un intervento precoce nei pazienti con SMM prima della progressione della malattia. L'approvazione si basa sul Phase 3 AQUILA study che ha valutato la monoterapia a durata fissa con daratumumab SC rispetto al monitoraggio attivo in pazienti con SMM ad alto rischio.
Halozyme Therapeutics (NASDAQ: HALO) anunci贸 que Janssen-Cilag recibi贸 la aprobaci贸n de la Comisi贸n Europea para DARZALEX Faspro庐, coformulado con la tecnolog铆a ENHANZE庐 de Halozyme, para el tratamiento del mieloma m煤ltiple smouldering de alto riesgo (SMM) en pacientes adultos.
Esta aprobaci贸n marca un cambio significativo respecto al actual est谩ndar de cuidado "Observar y Esperar", permitiendo una intervenci贸n temprana en pacientes con SMM antes de la progresi贸n de la enfermedad. La aprobaci贸n se basa en el estudio AQUILA de Fase 3, que evalu贸 la monoterapia de duraci贸n fija con daratumumab SC frente a la monitorizaci贸n activa en pacientes con SMM de alto riesgo.
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鞚措矆 鞀轨澑鞚� 順勳灛鞚� "甏�彀� 氚� 雽�旮�" 旃橂 響滌鞐愳劀 欷戩殧頃� 鞝勴櫂鞝愳澊 霅橂┌, 歆堧硲 歆勴枆 鞝勳棎 SMM 頇橃瀽鞐� 雽�頃� 臁瓣赴 臧滌瀰鞚� 臧�電ロ晿瓴� 頃╇媹雼�. 鞀轨澑鞚� 瓿犾渼項� SMM 頇橃瀽鞐愳劀 瓿犾爼 旮瓣皠 雼弲 鞖旊矔鞚� daratumumab SC鞕� 鞝侁饭鞝� 氇媹韯半鞚� 牍勱祼 韽夑皜頃� 3靸� AQUILA 鞐瓣惮毳� 旮半皹鞙茧 頃╇媹雼�.
Halozyme Therapeutics (NASDAQ : HALO) a annonc茅 que Janssen-Cilag a obtenu l'approbation de la Commission europ茅enne pour DARZALEX Faspro庐, coformul茅 avec la technologie ENHANZE庐 de Halozyme, pour le traitement du my茅lome multiple smouldering 脿 haut risque (SMM) chez les patients adultes.
Cette approbation marque un changement important par rapport 脿 la prise en charge actuelle "Surveillance active", permettant une intervention pr茅coce chez les patients atteints de SMM avant la progression de la maladie. L'approbation repose sur l'茅tude AQUILA de phase 3 茅valuant la monoth茅rapie 脿 dur茅e fixe de daratumumab SC versus la surveillance active chez les patients 脿 haut risque de SMM.
Halozyme Therapeutics (NASDAQ: HALO) gab bekannt, dass Janssen-Cilag die Zulassung der Europ盲ischen Kommission f眉r DARZALEX Faspro庐 erhalten hat, das mit der ENHANZE庐-Technologie von Halozyme koformuliert ist, zur Behandlung von Hochrisiko-smouldering-multiplem Myelom (SMM) bei erwachsenen Patienten.
Diese Zulassung markiert eine bedeutende Abkehr vom bisherigen Standard "Beobachten und Abwarten" und erm枚glicht eine fr眉hzeitige Intervention bei SMM-Patienten vor dem Fortschreiten der Erkrankung. Die Zulassung basiert auf der Phase-3 AQUILA-Studie, in der eine fixe Dauer der Monotherapie mit subkutanem Daratumumab gegen眉ber aktivem Monitoring bei Hochrisiko-SMM-Patienten untersucht wurde.
- 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
- None.
DARZALEX Faspro庐 is co-formulated with Halozyme's ENHANZE庐 drug delivery technology
Approval represents critical advancement in early intervention for 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庐 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庐 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庐 and XYOSTED庐, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.
Halozyme is headquartered in
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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庐, the possible method of action of ENHANZE庐, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE庐 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庐 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.
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FAQ
What is the new European Commission approval for DARZALEX Faspro with HALO's ENHANZE technology?
How does this approval impact Halozyme's (HALO) market position?
What clinical trial supported the EC approval of DARZALEX Faspro for SMM?
What is the current standard of care for smouldering multiple myeloma that DARZALEX Faspro will replace?
What is smouldering multiple myeloma (SMM)?
