Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb received a positive CHMP opinion recommending approval for a new subcutaneous formulation of Opdivo® (nivolumab) developed with ENHANZE® technology across multiple adult solid tumor indications in the EU.
The subcutaneous formulation, which utilizes Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), would offer cancer patients a faster and more flexible treatment option. The European Commission's decision on marketing authorization is expected by June 2, 2025.
The recommendation is supported by positive Phase 3 CheckMate -67T trial results. The formulation was previously approved in the U.S. on December 27, 2024 under the brand name Opdivo Qvantig.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che Bristol Myers Squibb ha ricevuto un parere positivo dal CHMP che raccomanda l'approvazione di una nuova formulazione sottocutanea di Opdivo® (nivolumab) sviluppata con la tecnologia ENHANZE® per diverse indicazioni di tumori solidi negli adulti nell'UE.
La formulazione sottocutanea, che utilizza l'enzima ricombinante umano ialuronidasi (rHuPH20) proprietario di Halozyme, offrirebbe ai pazienti affetti da cancro un'opzione di trattamento più rapida e flessibile. La decisione della Commissione Europea sull'autorizzazione alla commercializzazione è attesa entro il 2 giugno 2025.
La raccomandazione è supportata da risultati positivi della fase 3 dello studio CheckMate -67T. La formulazione era stata precedentemente approvata negli Stati Uniti il 27 dicembre 2024 con il nome commerciale Opdivo Qvantig.
Halozyme Therapeutics (NASDAQ: HALO) anunció que Bristol Myers Squibb recibió una opinión positiva del CHMP recomendando la aprobación de una nueva formulación subcutánea de Opdivo® (nivolumab) desarrollada con la tecnología ENHANZE® para múltiples indicaciones de tumores sólidos en adultos en la UE.
La formulación subcutánea, que utiliza la enzima recombinante humana hialuronidasa (rHuPH20) de Halozyme, ofrecería a los pacientes con cáncer una opción de tratamiento más rápida y flexible. Se espera que la decisión de la Comisión Europea sobre la autorización de comercialización se tome antes del 2 de junio de 2025.
La recomendación está respaldada por resultados positivos del ensayo de fase 3 CheckMate -67T. La formulación fue aprobada previamente en EE. UU. el 27 de diciembre de 2024 bajo el nombre de marca Opdivo Qvantig.
Halozyme Therapeutics (NASDAQ: HALO)는 Bristol Myers Squibb가 EU에서 여러 성인 고형 종양 적응증에 대해 ENHANZE® 기술로 개발된 Opdivo® (nivolumab)의 새로운 피하 제형 승인을 권장하는 긍정적인 CHMP 의견을 받았다고 발표했습니다.
Halozyme의 독점 재조합 인간 히알루로니다제 효소 (rHuPH20)를 활용하는 피하 제형은 암 환자에게 더 빠르고 유연한 치료 옵션을 제공할 것입니다. 유럽연합 집행위원회의 마케팅 승인 결정은 2025년 6월 2일까지 예상됩니다.
이 추천은 긍정적인 3상 CheckMate -67T 시험 결과에 의해 뒷받침됩니다. 이 제형은 이전에 2024년 12월 27일 미국에서 Opdivo Qvantig라는 상표명으로 승인되었습니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé que Bristol Myers Squibb a reçu un avis positif du CHMP recommandant l'approbation d'une nouvelle formulation sous-cutanée de Opdivo® (nivolumab) développée avec la technologie ENHANZE® pour plusieurs indications de tumeurs solides chez les adultes dans l'UE.
La formulation sous-cutanée, qui utilise l'enzyme hyaluronidase humaine recombinante (rHuPH20) propriétaire de Halozyme, offrirait aux patients atteints de cancer une option de traitement plus rapide et plus flexible. La décision de la Commission européenne concernant l'autorisation de mise sur le marché est attendue d'ici le 2 juin 2025.
La recommandation est soutenue par des résultats positifs de l'essai de phase 3 CheckMate -67T. La formulation a été précédemment approuvée aux États-Unis le 27 décembre 2024 sous le nom de marque Opdivo Qvantig.
Halozyme Therapeutics (NASDAQ: HALO) gab bekannt, dass Bristol Myers Squibb eine positive CHMP-Empfehlung erhalten hat, die die Genehmigung einer neuen subkutanen Formulierung von Opdivo® (nivolumab) empfiehlt, die mit der ENHANZE®-Technologie für mehrere Indikationen bei Erwachsenen mit soliden Tumoren in der EU entwickelt wurde.
Die subkutane Formulierung, die das proprietäre rekombinante menschliche Hyaluronidase-Enzym (rHuPH20) von Halozyme nutzt, würde Krebspatienten eine schnellere und flexiblere Behandlungsoption bieten. Die Entscheidung der Europäischen Kommission über die Marktzulassung wird bis zum 2. Juni 2025 erwartet.
Die Empfehlung wird durch positive Ergebnisse der Phase-3-Studie CheckMate -67T unterstützt. Die Formulierung wurde zuvor am 27. Dezember 2024 in den USA unter dem Markennamen Opdivo Qvantig genehmigt.
- CHMP positive opinion received for subcutaneous Opdivo with ENHANZE technology
- FDA approval already secured in December 2024
- Expands application of ENHANZE technology across multiple solid tumor indications
- None.
Insights
Halozyme's announcement of Bristol Myers Squibb receiving a positive CHMP opinion for subcutaneous Opdivo utilizing ENHANZE® technology represents a significant commercial advancement for Halozyme's drug delivery platform. This recommendation encompasses multiple solid tumor indications and builds upon the December 2024 FDA approval of Opdivo Qvantig in the U.S.
This development validates Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) platform as a facilitator for subcutaneous administration of traditionally intravenous biologics. For Halozyme, each commercial implementation of ENHANZE typically generates tiered royalties on net sales plus potential milestone payments, though specific financial terms for this particular agreement weren't disclosed.
The subcutaneous formulation offers substantial clinical advantages including reduced administration time compared to IV infusions, potentially expanding Opdivo's competitive positioning against rival checkpoint inhibitors. With European Commission approval expected by June 2, 2025, this represents a near-term potential revenue catalyst for Halozyme.
Bristol Myers Squibb's Phase 3 CheckMate -67T trial provided the efficacy and safety data supporting this recommendation, suggesting the subcutaneous formulation maintained Opdivo's therapeutic profile while offering administration benefits. For Halozyme, this advancement bolsters its technology's commercial viability in high-value oncology applications while potentially reducing healthcare resource utilization – a key selling point for future ENHANZE partnerships.
A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025
The CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union. A decision on the European extension of marketing authorization for the subcutaneous formulation of Opdivo is expected by June 2, 2025.
"We are delighted that the subcutaneous formulation of Opdivo developed with Halozyme's ENHANZE drug delivery technology was recommended for approval in the European Union. Subcutaneous delivery of Opdivo would provide cancer patients a faster and more flexible treatment option and may help alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme.
The CHMP positive opinion is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb's press release issued on March 28, 2025.
On December 27, 2024, nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the
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 alleviating pressure on healthcare system resources, 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. 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 and the timing of such potential approval. 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 delayed or ultimately approved, unexpected results or delays in the launch or commercialization of our partner's product for the indications 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/halozyme-announces-bristol-myers-squibb-received-positive-chmp-opinion-for-the-subcutaneous-formulation-of-opdivo-nivolumab-with-enhanze-across-multiple-solid-tumor-indications-302415538.html
SOURCE Halozyme Therapeutics, Inc.
FAQ
When is the EU approval decision expected for Halozyme's subcutaneous Opdivo formulation (HALO)?
What are the benefits of Halozyme's ENHANZE technology for Opdivo administration (HALO)?
When did the FDA approve Halozyme's subcutaneous Opdivo formulation (HALO)?
Which clinical trial supported the CHMP positive opinion for Halozyme's subcutaneous Opdivo (HALO)?
