DAIICHI-SANKYO-CO
6.7.2020 08:02:10 CEST | Business Wire | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC), for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
Validation confirms that the application is complete and commences the scientific review process by the EMA’s CHMP. Accelerated assessment is granted by the CHMP to products expected to be of major interest for public health and therapeutic innovation and can significantly reduce the review timelines.
“The accelerated assessment highlights the significant unmet need for patients with HER2 positive metastatic breast cancer that trastuzumab deruxtecan aims at addressing,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Trastuzumab deruxtecan is already available for patients in the U.S. and Japan, and we look forward to working with the EMA to bring this important new medicine to patients in the EU as quickly as possible.”
The MAA is based on the positive results from the pivotal phase 2 DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive metastatic breast cancer who had received two or more prior anti-HER2 regimens. The results of the DESTINY-Breast01 trial are published in The New England Journal of Medicine .
About HER2
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including gastric, breast and lung cancers. HER2 overexpression is associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poorer prognosis.1
About HER2 Positive Breast Cancer
Approximately one in five breast cancers are HER2 positive.2,3 Despite recent improvements and approvals of new medicines, there remain significant clinical needs for patients with HER2 positive metastatic breast cancer.4,5 This disease remains incurable with patients eventually progressing after available treatment.5
About Trastuzumab Deruxtecan
Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is comprised of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker.
Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based regimens based on the DESTINY-Breast01 trial.
Trastuzumab deruxtecan has not been approved in the EU, or countries outside of Japan and the U.S., for any indication. It is an investigational agent globally for various indications.
About the Trastuzumab Deruxtecan Clinical Development Program
A comprehensive development program for trastuzumab deruxtecan is underway globally with six pivotal trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 cancers including breast, gastric, and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.
In May 2020, trastuzumab deruxtecan received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab, and Orphan Drug Designation for gastric cancer, including gastroesophageal junction cancer. In March 2018, trastuzumab deruxtecan received a SAKIGAKE designation for potential use in the same HER2positive patient population and a supplemental New Drug Application was submitted to the Japan Ministry of Health, Labour and Welfare (MHLW) for approval in April 2020.
In May 2020, trastuzumab deruxtecan also received Breakthrough Therapy Designation for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy.
About the Collaboration between Daiichi Sankyo and AstraZeneca
In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan worldwide, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is solely responsible for the manufacturing and supply.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com
References :
1 Iqbal N, et al. Mol Biol Int . 2014; 2014: 852748
2 Tandon A, et al. J Clin Oncol . 1989;7(8):1120-8.
3 Sledge G, et al. J Clin Oncol . 2014;32(19):1979-1986.
4 de Melo Gagliato D, et al. Oncotarget . 2016;7(39):64431-46.
5 National Comprehensive Cancer Network (NCCN). NCCN Guidelines. Breast Cancer. Accessed June 2020.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200705005027/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Consulting styrker sit cybersikkerhedstilbud gennem samarbejde med Trillium Information Security Systems21.3.2026 02:16:00 CET | Pressemeddelelse
Andersen Consulting udbygger sine kompetencer inden for teknologi og risikostyring gennem en samarbejdsaftale med Trillium Information Security Systems (TISS), et cybersikkerhedsfirma. Med en tilstedeværelse i Canada og Pakistan leverer TISS omfattende cybersikkerhedsløsninger til organisationer inden for finans, telekommunikation og den offentlige sektor. Virksomhedens team tilbyder et bredt udvalg af ydelser, herunder sikkerhedsvurderinger, managed security operations, red team-tjenester, digital efterforskning og hændelsesrespons samt GRC-rådgivning. Med næsten to årtiers erfaring leverer TISS adaptive, efterretningsdrevne forsvarsmekanismer, der hjælper kunder med at forudse og reagere på cybertrusler, der er i konstant udvikling. "Hos TISS arbejder vi på at skabe et mere sikkert digitalt miljø ved at give organisationer mulighed for at operere sikkert og med selvtillid," udtalte Mahir Mohsin Sheikh, administrerende direktør for TISS. "Vores samarbejde med Andersen Consulting giver
Andersen Consulting udvider sin teknologiplatform i Frankrig20.3.2026 17:28:00 CET | Pressemeddelelse
Andersen Consulting udvider sit udbud inden for digital transformation med en samarbejdsaftale med Teolia Consulting, et fransk firma, der specialiserer sig i projekt- og produktstyring, cloud-platformsudvikling, datatransformation samt implementering og brug af Atlassian-pakken. Teolia Consulting blev grundlagt i 2014 og hjælper organisationer med at opnå digital performance, fra agile metoder til løsninger, der reducerer lanceringstiden. Virksomhedens ekspertise består i at levere integrerede strategier, der bringer teknologi og organisatorisk forandring i overensstemmelse. Virksomheden arbejder på tværs af brancher, herunder inden for bank- og finanssektoren, forsikring, mode og detailhandel, og hjælper kunder med at få større robusthed og accelerere deres digitale modenhed. "Hos Teolia Consulting mener vi, at ægte transformation opstår, når teknologi og mennesker udvikler sig sammen," sagde Lucienne Jacquet, der er administrerende partner i Teolia. "Ved at samarbejde med Andersen C
Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting20.3.2026 15:00:00 CET | Press release
- New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted - Featured abstracts for ruxolitinib cream (Opzelura®) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver. “At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.” Details on key data presentation
MUSASHI JAPAN by TAIMATSU Launches “Road to Shogun” – A Journey Through Craftsmanship and Discovery20.3.2026 13:58:00 CET | Press release
Musashi Japan by TAIMATSU Co., Ltd., a contemporary Japanese knife brand rooted in the spirit of craftsmanship and cultural harmony, has announced its newest experiential campaign: “Road to Shogun.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320887471/en/ Designed as the brand’s most ambitious customer journey to date, the campaign invites visitors to explore participating Musashi Japan stores while discovering the traditions, culture and craftsmanship that inspire the brand. Inspired by the journey towards mastery, the experience encourages participants to progress through a series of ranks whilst visiting stores and unlocking rewards that celebrate elements of everyday Japanese culture. At Musashi Japan, craftsmanship is not only about the final product, but also about the path taken to achieve mastery. The Road to Shogun reflects this philosophy by guiding customers through a journey that mirrors the dedication, cu
Futur Delivers Strong Growth and Record Profit in 202520.3.2026 12:05:00 CET | Press release
In 2025, Futur added 21,000 new customers and the inflows amounted to 34 billion kronor. At the end of the year, the total savings capital was 252 billion kronor, an increase of 7% from the previous year and a new record level. "2025 was a record year for Futur. In a market characterized by sharp market fluctuations, Futur continued to invest, grow and deliver strong results. Behind this record performance is stable customer growth, strong inflows and cost discipline. Our close cooperation with over 60 partners gives customers the freedom to choose the asset management and advisory services that best suit them. The strategy of letting the customer choose is appreciated, which is reflected in us welcoming more than 21,000 new customers during the year", says Torgny Johansson, CEO of Futur. "We are optimistic about the future. Futur has great opportunities to continue growing in the coming years by developing innovative and efficient services for savings and pensions. I am proud of how a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom