Halozyme Announces FDA Approval of Roche's Tecentriq Hybreza™ With ENHANZE® for Multiple Types of Cancer
Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval for Roche's Tecentriq Hybreza™, the first subcutaneous anti-PD-(L)1 cancer immunotherapy. This treatment, incorporating Halozyme's ENHANZE® technology, can be administered in about 7 minutes, compared to 30-60 minutes for standard IV infusion. Tecentriq Hybreza™ is approved for all adult indications of IV Tecentriq®, including certain types of lung, liver, skin, and soft tissue cancers. The approval is based on Roche's Phase IB/III IMscin001 study, which demonstrated comparable blood levels of Tecentriq® when given subcutaneously, with a consistent safety and efficacy profile to the IV formulation.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato l'approvazione da parte della FDA per Tecentriq Hybreza™ di Roche, il primo trattamento immunoterapico anti-PD-(L)1 sottocutaneo. Questo trattamento, che utilizza la tecnologia ENHANZE® di Halozyme, può essere somministrato in circa 7 minuti, rispetto ai 30-60 minuti richiesti per la somministrazione endovenosa standard. Tecentriq Hybreza™ è approvato per tutte le indicazioni per adulti relative a Tecentriq® endovenoso, comprese alcune tipologie di cancro ai polmoni, al fegato, alla pelle e tumori dei tessuti molli. L'approvazione si basa sullo studio di Roche di fase IB/III IMscin001, che ha dimostrato livelli ematici comparabili di Tecentriq® quando somministrato sottocutaneamente, con un profilo di sicurezza ed efficacia coerente con la formulazione endovenosa.
Halozyme Therapeutics (NASDAQ: HALO) anunció la aprobación de la FDA para Tecentriq Hybreza™ de Roche, la primera inmunoterapia anti-PD-(L)1 subcutánea para cáncer. Este tratamiento, que incorpora la tecnología ENHANZE® de Halozyme, se puede administrar en aproximadamente 7 minutos, en comparación con los 30-60 minutos requeridos para la infusión intravenosa estándar. Tecentriq Hybreza™ está aprobado para todas las indicaciones en adultos del Tecentriq® intravenoso, incluidas ciertos tipos de cáncer de pulmón, hígado, piel y tejidos blandos. La aprobación se basa en el estudio de fase IB/III IMscin001 de Roche, que demostró niveles de Tecentriq® en sangre comparables cuando se administró subcutáneamente, con un perfil de seguridad y eficacia consistente con la formulación intravenosa.
Halozyme Therapeutics (NASDAQ: HALO)는 Roche의 Tecentriq Hybreza™에 대한 FDA 승인을 발표했습니다. 이는 첫 번째 피하 항-PD-(L)1 암 면역 요법입니다. Halozyme의 ENHANZE® 기술을 통합한 이 치료법은 표준 IV 주입의 30-60분에 비해 약 7분 만에 투여될 수 있습니다. Tecentriq Hybreza™는 IV Tecentriq®의 모든 성인 적응증에 대해 승인되었으며, 여기에는 특정 유형의 폐, 간, 피부 및 연조직 암이 포함됩니다. 이 승인은 Roche의 임상 연구인 Phase IB/III IMscin001에 기반하고 있으며, 피하 투여 시 Tecentriq®의 혈중 수준이 유사하게 나타났고, IV 제형과 일관된 안전성 및 효능 프로파일을 보여주었습니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé l'approbation de la FDA pour Tecentriq Hybreza™ de Roche, le premier traitement immunothérapeutique anti-PD-(L)1 sous-cutané. Ce traitement, intégrant la technologie ENHANZE® de Halozyme, peut être administré en environ 7 minutes, contre 30 à 60 minutes pour l'infusion intraveineuse standard. Tecentriq Hybreza™ est approuvé pour toutes les indications chez les adultes du Tecentriq® intraveineux, y compris certains types de cancers des poumons, du foie, de la peau et des tissus mous. L'approbation est basée sur l'étude de phase IB/III IMscin001 de Roche, qui a démontré des niveaux de Tecentriq® dans le sang comparables lorsqu'il est administré par voie sous-cutanée, avec un profil de sécurité et d'efficacité cohérent avec la formulation intraveineuse.
Halozyme Therapeutics (NASDAQ: HALO) gab die Zulassung von Tecentriq Hybreza™ durch die FDA bekannt, die erste subkutane anti-PD-(L)1-Krebsimmuntherapie. Diese Behandlung, die die ENHANZE®-Technologie von Halozyme nutzt, kann in etwa 7 Minuten verabreicht werden, im Vergleich zu 30-60 Minuten für die Standard-IV-Infusion. Tecentriq Hybreza™ ist für alle Erwachsenenindikationen von IV Tecentriq® zugelassen, einschließlich bestimmter Arten von Lungen-, Leber-, Haut- und Weichgewebekrebs. Die Zulassung basiert auf der Phase IB/III IMscin001-Studie von Roche, die vergleichbare Blutspiegel von Tecentriq® bei subkutaner Verabreichung zeigte, mit einem konsistenten Sicherheits- und Wirksamkeitsprofil im Vergleich zur IV-Formulierung.
- FDA approval of Tecentriq Hybreza™ with ENHANZE® technology for multiple cancer types
- First and only subcutaneous anti-PD-(L)1 cancer immunotherapy approved
- Significantly reduced administration time (7 minutes vs 30-60 minutes for IV)
- Approved for all adult indications of IV Tecentriq®, expanding market potential
- Comparable efficacy and safety profile to IV formulation based on clinical study results
- None.
Insights
The FDA approval of Tecentriq Hybreza™ marks a significant advancement in cancer immunotherapy delivery. This subcutaneous formulation, utilizing Halozyme's ENHANZE® technology, dramatically reduces administration time from 30-60 minutes to just 7 minutes. This improvement could potentially enhance patient comfort and clinic efficiency.
The approval, based on the IMscin001 study, demonstrates comparable pharmacokinetics and safety profiles to the IV formulation. This suggests that the subcutaneous route doesn't compromise the drug's effectiveness. The broad approval across multiple cancer types (
For Halozyme, this approval validates their ENHANZE® platform and could lead to increased adoption in other therapies. For patients and healthcare providers, it offers a more convenient option without sacrificing efficacy, potentially improving treatment adherence and quality of life.
This FDA approval is a major catalyst for Halozyme (NASDAQ: HALO). As the first subcutaneous anti-PD-(L)1 cancer immunotherapy, Tecentriq Hybreza™ has a significant first-mover advantage in a highly competitive market. This could translate to substantial royalty revenues for Halozyme from Roche's sales.
The approval across multiple cancer indications expands the potential market size considerably. Given that Tecentriq® is one of Roche's top-selling drugs (
Moreover, this success could attract more partnerships for Halozyme's ENHANZE® technology, potentially leading to long-term growth in licensing and milestone revenues. Investors should monitor adoption rates and any guidance on financial projections in upcoming earnings calls.
The approval of Tecentriq Hybreza™ represents a paradigm shift in cancer immunotherapy administration. The subcutaneous route offers several advantages over IV infusion, including reduced chair time, potentially fewer infusion-related reactions and improved patient convenience. This could lead to better treatment adherence and potentially improved outcomes.
The broad approval across multiple cancer types is particularly noteworthy. It suggests that the subcutaneous formulation maintains efficacy across various tumor types, which is important for a versatile immunotherapy like atezolizumab. The consistent safety and efficacy profile with the IV formulation is reassuring for clinicians considering this new option.
However, it's important to note that long-term follow-up data will be crucial to ensure that the subcutaneous route doesn't compromise long-term efficacy or introduce unexpected side effects. Clinicians will likely monitor real-world data closely as this new formulation is adopted into practice.
FDA approval marks first and only subcutaneous anti-PD-(L)1 cancer immunotherapy
Tecentriq Hybreza™ is a subcutaneous product combination of atezolizumab, a monoclonal antibody that targets PD-(L)1 aiming to prevent cancer immune evasion, and Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20.
"We are delighted that Tecentriq Hybreza has been approved in the
The FDA approval is based on pivotal data from Roche's Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.
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 more than 800,000 patient lives in post-marketing use in eight 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 several pharmaceutical companies including 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 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 "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 new ENHANZE® collaborative products are ultimately developed, approved or commercialized, unexpected results or delays in launch or commercialization of our partner's product referred to in this press release, unexpected adverse events or patient 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.
Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
FAQ
What is Tecentriq Hybreza™ and what cancers is it approved to treat?
How does Tecentriq Hybreza™ administration time compare to IV Tecentriq®?
What study supported the FDA approval of Tecentriq Hybreza™?
How does the approval of Tecentriq Hybreza™ impact Halozyme Therapeutics (HALO)?
