CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Roche received a positive CHMP recommendation for updating the EU label of Phesgo, allowing its administration outside clinical settings. Phesgo, a subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer, could soon be administered at home by healthcare professionals.
Key highlights:
- Treatment costs could be reduced by up to 80% in Western Europe
- 85% of patients prefer subcutaneous over IV administration
- 91% of patients favor at-home treatment over in-clinic options
- Nearly half a million people are diagnosed with HER2-positive breast cancer worldwide annually
The recommendation is backed by clinical, real-world, and bioequivalence data showing feasibility and safety of at-home administration. Phesgo is currently approved in over 120 countries/regions as a subcutaneous alternative to intravenous treatment for both early-stage and metastatic HER2-positive breast cancer.
Roche ha ricevuto una raccomandazione positiva dal CHMP per l'aggiornamento del foglietto illustrativo europeo di Phesgo, che ne consente la somministrazione al di fuori degli ambienti clinici. Phesgo, una combinazione sottocutanea di Perjeta e Herceptin per il carcinoma mammario HER2-positivo, potrebbe presto essere somministrato a domicilio da operatori sanitari.
Punti chiave:
- I costi del trattamento potrebbero ridursi fino all'80% in Europa occidentale
- l'85% dei pazienti preferisce la somministrazione sottocutanea rispetto a quella endovenosa
- il 91% dei pazienti preferisce il trattamento a domicilio rispetto a quello in clinica
- Quasi mezzo milione di persone nel mondo viene diagnosticato ogni anno con carcinoma mammario HER2-positivo
La raccomandazione è supportata da dati clinici, real-world e di bioequivalenza che dimostrano la fattibilità e la sicurezza della somministrazione a domicilio. Phesgo è attualmente approvato in oltre 120 paesi/regioni come alternativa sottocutanea al trattamento endovenoso sia per il carcinoma mammario HER2-positivo in fase iniziale che metastatica.
Roche recibió una recomendación positiva del CHMP para actualizar la etiqueta de la UE de Phesgo, permitiendo su administración fuera de entornos clínicos. Phesgo, una combinación subcutánea de Perjeta y Herceptin para el cáncer de mama HER2 positivo, podría administrarse pronto en casa por profesionales de la salud.
Puntos clave:
- Los costos del tratamiento podrían reducirse hasta en un 80% en Europa occidental
- El 85% de los pacientes prefieren la administración subcutánea sobre la intravenosa
- El 91% de los pacientes prefieren el tratamiento en casa sobre las opciones en clínica
- Casi medio millón de personas son diagnosticadas anualmente con cáncer de mama HER2 positivo en todo el mundo
La recomendación está respaldada por datos clínicos, del mundo real y de bioequivalencia que demuestran la viabilidad y seguridad de la administración en casa. Phesgo está aprobado actualmente en más de 120 países/regiones como una alternativa subcutánea al tratamiento intravenoso para el cáncer de mama HER2 positivo en estadios tempranos y metastásicos.
로슈가 페스고(Phesgo)의 EU 라벨 업데이트에 대해 CHMP로부터 긍정적인 권고를 받았습니다. 이를 통해 임상 환경 밖에서도 투여가 가능해졌습니다. 페스고는 HER2 양성 유방암 치료를 위한 퍼제타와 허셉틴의 피하주사 조합으로, 곧 의료 전문가에 의해 가정에서 투여될 수 있습니다.
주요 내용:
- 서유럽에서 치료 비용이 최대 80%까지 절감될 수 있음
- 환자의 85%가 정맥주사보다 피하주사를 선호함
- 환자의 91%가 병원 내 치료보다 가정 치료를 선호함
- 전 세계적으로 매년 약 50만 명이 HER2 양성 유방암 진단을 받음
이 권고는 임상, 실제 사용, 생물학적 동등성 데이터를 통해 가정 투여의 타당성과 안전성을 입증한 결과입니다. 페스고는 현재 120개 이상의 국가 및 지역에서 조기 및 전이성 HER2 양성 유방암에 대해 정맥주사 대체 피하주사로 승인되어 있습니다.
Roche a reçu une recommandation positive du CHMP pour la mise à jour du label européen de Phesgo, autorisant son administration en dehors des établissements cliniques. Phesgo, une combinaison sous-cutanée de Perjeta et Herceptin pour le cancer du sein HER2-positif, pourrait bientôt être administré à domicile par des professionnels de santé.
Points clés :
- Les coûts de traitement pourraient être réduits jusqu'à 80 % en Europe de l'Ouest
- 85 % des patients préfèrent l'administration sous-cutanée à la perfusion intraveineuse
- 91 % des patients favorisent le traitement à domicile plutôt qu'en clinique
- Près d'un demi-million de personnes sont diagnostiquées chaque année avec un cancer du sein HER2-positif dans le monde
Cette recommandation est étayée par des données cliniques, en conditions réelles et de bioéquivalence démontrant la faisabilité et la sécurité de l'administration à domicile. Phesgo est actuellement approuvé dans plus de 120 pays/régions comme alternative sous-cutanée au traitement intraveineux pour le cancer du sein HER2-positif à un stade précoce ou métastatique.
Roche erhielt eine positive CHMP-Empfehlung für die Aktualisierung des EU-Labels von Phesgo, die die Verabreichung außerhalb klinischer Einrichtungen ermöglicht. Phesgo, eine subkutane Kombination aus Perjeta und Herceptin zur Behandlung von HER2-positivem Brustkrebs, könnte bald von medizinischem Fachpersonal zu Hause verabreicht werden.
Wichtige Punkte:
- Die Behandlungskosten könnten in Westeuropa um bis zu 80 % gesenkt werden
- 85 % der Patienten bevorzugen die subkutane gegenüber der intravenösen Verabreichung
- 91 % der Patienten bevorzugen die Behandlung zu Hause gegenüber der Klinik
- Weltweit werden jährlich fast eine halbe Million Menschen mit HER2-positivem Brustkrebs diagnostiziert
Die Empfehlung basiert auf klinischen, Real-World- und Bioäquivalenz-Daten, die die Machbarkeit und Sicherheit der Behandlung zu Hause belegen. Phesgo ist derzeit in über 120 Ländern/Regionen als subkutane Alternative zur intravenösen Behandlung sowohl des frühen als auch des metastasierten HER2-positiven Brustkrebses zugelassen.
- Potential 80% reduction in treatment administration costs in Western Europe by switching to Phesgo
- High patient preference with 85% favoring SC over IV administration, indicating strong market adoption potential
- Already approved in 120+ countries/regions, showing strong global market penetration
- Label expansion could reduce healthcare system costs and increase treatment accessibility
- Positive CHMP recommendation suggests high likelihood of EU approval for at-home administration
- HER2-positive breast cancer economic burden expected to increase from $590B to $1,000B by 2032, potentially affecting treatment accessibility and reimbursement
- Requires healthcare professional for at-home administration, limiting full cost reduction potential
- Positive recommendation based on clinical, real-world and bioequivalence data supporting feasibility and safety of Phesgo’s administration outside of clinical settings, for example at home1-4
- Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings3
- Phesgo has the potential to reduce treatment administration costs by up to
80% in Western Europe, and85% of patients prefer SC over IV administration.7,3
Basel, 30 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo®, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. If approved, administration of Phesgo outside of a clinical setting (such as in a person’s home) by a healthcare professional will be possible, once safely established in a clinical setting. A final decision regarding the approval is expected from the European Commission in the near future.
Each year, almost half a million people are diagnosed with HER2-positive breast cancer worldwide and treatment can impact a person’s ability to work and contribute to society.5,6
"Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly
"Treatments, like Phesgo, that can be administered at home offer patients a more manageable option, with the potential to improve their quality of life," said Sandrine Lavallé from European Patients Academy on Therapeutic Innovation (EUPATI), Luxembourg. "This reduces the burden of hospital commuting time, anxiety associated with being in a hospital infusion chair, and minimizes disruption to daily life. Patient safety is paramount, requiring clear instructions, education, and support for at-home treatment."
The CHMP positive opinion is supported by results from clinical, real-world and bioequivalence data, drug safety reports and the United States expanded access study, AL42478, in people with early-stage and metastatic HER2-positive breast cancer, which demonstrated that at-home administration of Phesgo by a healthcare professional was feasible, preferred by patients, and with no new safety signals observed.1-4
Phesgo is already approved as a SC alternative to intravenous (IV) Perjeta and Herceptin for people with HER2-positive early-stage and metastatic breast cancer in more than 120 countries/regions. In Western Europe, switching from IV Perjeta and Herceptin to Phesgo has been shown to reduce treatment administration costs by up to
About Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous (SC))
Phesgo is a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by SC (under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early-stage and metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
The standard IV formulation of Perjeta in combination with IV Herceptin and chemotherapy (the Perjeta-based regimen) is approved in more than 120 countries/regions for the treatment of both early-stage and metastatic HER2-positive breast cancer. In the neoadjuvant (before surgery) early-stage breast cancer setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.8 Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) early-stage breast cancer setting.9 In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.10 Phesgo offers faster administration of Perjeta and Herceptin under the skin in approximately eight minutes, compared to hours with standard IV administration.11-13
About Roche’s medicines for human epidermal growth factor receptor 2 (HER2)-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early-stage and advanced HER2-positive disease. HER2-positive breast cancer affects approximately 15
Survival outcomes for people with HER2-positive breast cancer, once was seen as an aggressive type of the disease, have been transformed through the development of targeted therapies, including Roche molecules Herceptin® (trastuzumab), Perjeta® (pertuzumab), Kadcyla® (trastuzumab emtansine) and Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous). Long-term survival is now a possibility for many people, which also contributes to societal and economic benefits. Between 2017 to 2023, Roche's HER2-positive breast cancer medicines contributed a cumulative
Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.
About Roche in breast cancer
Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.14,15
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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References
[1] Tan A, et al. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. The Lancet Oncology. 2021;22(1):85-97.
[2] O'Shaughnessy J, et al. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021:152:223-232.
[3] Dang C, et al. Preliminary analysis of an expanded access study of the fixed-dose combination of pertuzumab (P) and trastuzumab (H) for subcutaneous injection (PH FDC SC) for at-home administration (admin) in patients (pts) with HER2-positive (HER2+) breast cancer (BC) during the COVID-19 pandemic. Journal of Clinical Oncology. 2022;40(16):1515.
[4] ClinicalTrials.gov. A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System) [Internet; cited 2025 April]. Available from: https://clinicaltrials.gov/study/NCT05275010?term=WP42873&rank=1&tab=results.
[5] WifOR Institute. The value of investing in innovative medicines: Socioeconomic burden and annual social impact of Roche treatments for HER2 breast cancer, multiple sclerosis and retinal disease [Internet; cited 2025 April]. Available from: https://www.wifor.com/en/download/the-value-of-investing-in-innovative-medicines-socioeconomic-burden-and-annual-social-impact-of-roche-treatments-for-her2-breast-cancer-multiple-sclerosis-and-retinal-disease/?wpdmdl=351656&refresh=6734d834b606f1731516468.
[6] Ban M, Petrić Miše B, & Vrdoljak E. Early HER2-positive breast cancer: current treatment and novel approaches. Breast Care. 2020;15(6), 560-569.
[7] Manevy F, et al. Potential non-drug cost differences associated with the use of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in the treatment of HER2-positive early breast cancer patients in Western Europe and the United States. Presented at: ASCO Annual Meeting; 2021 Jun 4-8. Abstract #54.
[8] Gianni L, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 2012;13(1):25-32.
[9] Minckwitz G, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017;13;377(2):122-31.
[10] Swain SM, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;19;372(8):724-34.
[11] U.S. Food and Drug Administration. Prescribing information for Phesgo [Internet; cited April 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf.
[12] U.S. Food and Drug Administration. Prescribing Information for Herceptin [Internet; cited April 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.
[13] U.S. Food and Drug Administration. Prescribing information for Perjeta [Internet; cited April 2025]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf.
[14] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 April]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
[15] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.
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