CHMP Issues Positive Opinion for Subcutaneous RYBREVANT®(amivantamab) Co-Formulated with ENHANZE® for the Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen-Cilag International NV received a positive CHMP opinion recommending marketing authorization for a subcutaneous formulation of RYBREVANT® (amivantamab) in Europe. The recommendation covers two treatments: combination therapy with LAZCLUZE® for first-line treatment of advanced NSCLC with specific EGFR mutations, and monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
The subcutaneous formulation, developed using Halozyme's ENHANZE® technology, demonstrates significant advantages with an approximate five-minute administration time and a five-fold reduction in infusion-related reactions. The recommendation is supported by positive results from the Phase 3 PALOMA-3 study.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che Janssen-Cilag International NV ha ricevuto un parere positivo dal CHMP che raccomanda l'autorizzazione alla commercializzazione di una formulazione sottocutanea di RYBREVANT® (amivantamab) in Europa. La raccomandazione copre due trattamenti: terapia combinata con LAZCLUZE® per il trattamento di prima linea del NSCLC avanzato con specifiche mutazioni di EGFR, e monoterapia per NSCLC avanzato con mutazioni di inserzione dell'esone 20 di EGFR dopo il fallimento della terapia a base di platino.
La formulazione sottocutanea, sviluppata utilizzando la tecnologia ENHANZE® di Halozyme, dimostra vantaggi significativi con un tempo di somministrazione di circa cinque minuti e una riduzione di cinque volte delle reazioni correlate all'infusione. La raccomandazione è supportata da risultati positivi dello studio di fase 3 PALOMA-3.
Halozyme Therapeutics (NASDAQ: HALO) anunció que Janssen-Cilag International NV recibió un dictamen positivo del CHMP recomendando la autorización de comercialización para una formulación subcutánea de RYBREVANT® (amivantamab) en Europa. La recomendación abarca dos tratamientos: terapia combinada con LAZCLUZE® para el tratamiento de primera línea del NSCLC avanzado con mutaciones específicas de EGFR, y monoterapia para el NSCLC avanzado con mutaciones de inserción del exón 20 de EGFR después del fracaso de la terapia basada en platino.
La formulación subcutánea, desarrollada utilizando la tecnología ENHANZE® de Halozyme, demuestra ventajas significativas con un tiempo de administración de aproximadamente cinco minutos y una reducción de cinco veces en las reacciones relacionadas con la infusión. La recomendación está respaldada por resultados positivos del estudio de fase 3 PALOMA-3.
Halozyme Therapeutics (NASDAQ: HALO)는 Janssen-Cilag International NV가 유럽에서 RYBREVANT® (amivantamab)의 피하 주사형제제에 대한 긍정적인 CHMP 의견을 받았다고 발표했습니다. 이 추천은 두 가지 치료를 포함합니다: 특정 EGFR 돌연변이가 있는 진행성 NSCLC의 1차 치료를 위한 LAZCLUZE®와 플래티넘 기반 치료 실패 후 EGFR 엑손 20 삽입 돌연변이가 있는 진행성 NSCLC에 대한 단독 요법입니다.
Halozyme의 ENHANZE® 기술을 사용하여 개발된 피하 주사형제제는 약 5분의 약물 투여 시간과 주입 관련 반응의 5배 감소라는 상당한 장점을 보여줍니다. 이 추천은 3상 PALOMA-3 연구의 긍정적인 결과에 의해 뒷받침됩니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé que Janssen-Cilag International NV a reçu un avis positif du CHMP recommandant l'autorisation de mise sur le marché d'une formulation sous-cutanée de RYBREVANT® (amivantamab) en Europe. La recommandation couvre deux traitements : la thérapie combinée avec LAZCLUZE® pour le traitement de première ligne du NSCLC avancé avec des mutations spécifiques de l'EGFR, et la monothérapie pour le NSCLC avancé avec des mutations d'insertion de l'exon 20 de l'EGFR après un échec du traitement à base de platine.
La formulation sous-cutanée, développée en utilisant la technologie ENHANZE® de Halozyme, présente des avantages significatifs avec un temps d'administration d'environ cinq minutes et une réduction par cinq des réactions liées à l'infusion. La recommandation est soutenue par des résultats positifs de l'étude de phase 3 PALOMA-3.
Halozyme Therapeutics (NASDAQ: HALO) kündigte an, dass Janssen-Cilag International NV eine positive CHMP-Empfehlung für die Marktzulassung einer subkutanen Formulierung von RYBREVANT® (amivantamab) in Europa erhalten hat. Die Empfehlung umfasst zwei Behandlungen: eine Kombinationstherapie mit LAZCLUZE® für die Erstlinientherapie von fortgeschrittenem NSCLC mit bestimmten EGFR-Mutationen und Monotherapie für fortgeschrittenes NSCLC mit EGFR-Exon-20-Insertion-Mutationen nach dem Scheitern der Platin-basierten Therapie.
Die subkutane Formulierung, die mit der ENHANZE®-Technologie von Halozyme entwickelt wurde, zeigt erhebliche Vorteile mit einer ungefähren Verabreichungszeit von fünf Minuten und einer fünfmaligen Reduktion von behandlungsbezogenen Reaktionen. Die Empfehlung wird durch positive Ergebnisse der Phase-3-Studie PALOMA-3 gestützt.
- CHMP positive opinion for subcutaneous RYBREVANT® using Halozyme's ENHANZE® technology
- Five-fold reduction in infusion-related reactions compared to current formulation
- Significant reduction in administration time to approximately 5 minutes
- Expansion of ENHANZE® technology application in major therapeutic area
- None.
Insights
The CHMP's positive opinion for subcutaneous RYBREVANT marks a pivotal milestone for Halozyme's ENHANZE platform, substantially strengthening its position in the $20 billion NSCLC market. The recommendation's dual coverage for both first-line treatment and post-platinum therapy maximizes the commercial potential, while the dramatic reduction in administration time from hours to just 5 minutes represents a game-changing improvement in patient care.
The 5-fold reduction in infusion-related reactions is particularly significant as it addresses a major limitation of traditional IV administration, potentially leading to broader adoption and improved patient compliance. This validation from a major regulatory body strengthens Halozyme's partnership with Johnson & Johnson and could accelerate adoption of ENHANZE technology across other oncology programs.
For investors, this development carries three key implications: 1) Enhanced royalty potential from RYBREVANT sales in Europe, 2) Increased likelihood of additional pharmaceutical partnerships seeking to leverage ENHANZE technology and 3) Strengthened competitive moat in the drug delivery space. The positive CHMP opinion, supported by robust Phase 3 PALOMA-3 data, significantly de-risks the regulatory pathway and sets a precedent for future ENHANZE-enabled products.
"We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in
The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For more information on the study and its findings, please view Johnson & Johnson's press release issued today.
Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.
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.
2 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. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.
3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). https://clinicaltrials.gov/ct2/show/NCT05388669. Accessed January 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 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
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 reactionsand 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 is the significance of CHMP's positive opinion for HALO's ENHANZE® technology in RYBREVANT®?
How does the new subcutaneous formulation of RYBREVANT® improve patient treatment?
What indications will the subcutaneous RYBREVANT® cover according to CHMP's recommendation?
What clinical trial supported CHMP's positive opinion for subcutaneous RYBREVANT®?
