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
KATE Launches "KABUKE: Break Convention" Kabuki-Inspired International Campaign17.7.2026 09:00:00 CEST | Press release
Where “NO MORE RULES.” intersects with the Kabuku spirit. Inspired by Japanese aesthetics, KATE shares the value of shadow enhancing makeup and self‑expression with the world. Global cosmetics brand KATE launched “KABUKE: Break Convention,” a new international campaign drawing on elements of Kabuki, the traditional Japanese performing art. The campaign debuted on Wednesday, July 8, 2026. In this campaign, KATE’s shadow enhancing makeup—rooted in Japanese aesthetics—was paired with the Kabuki spirit inherited from traditional Kabuki theater to communicate the value of individuality and self‑expression through makeup on a global scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708829427/en/ KATE international campaign “KABUKE: Break Convention” key visual. Dedicated website: https://www.kate-global.net/my/special/kate_kabuki/ Since its founding, KATE has championed the slogan “NO MORE RULES.,” offering makeup that defi
Meiji Seika Pharma: Results from the Global Phase III Trial (Integral-2) of Nacubactam, a Novel β-Lactamase Inhibitor, Highlighted in The Lancet Microbe’s Coverage of ESCMID Global Congress 202617.7.2026 03:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that results from the global Phase III trial (Integral-2) of nacubactam (Development Code: OP0595), a novel β-lactamase inhibitor, were highlighted in The Lancet Microbe’s coverage of ESCMID Global Congress 2026 (held in Munich, Germany). As highlighted in The Lancet Microbe’s coverage, the key findings presented by Meiji Seika Pharma at ESCMID Global Congress 2026 are as follows: The Integral-2 study (jRCT2031230076) is a global Phase III clinical trial that enrolled patients with complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, or complicated intra-abdominal infections caused by carbapenem-resistant Gram-negative bacteria (excluding Acinetobacter species). The study has achieved the prespecified study objectives. For the primary endpoint of overall treatme
Yoshihiro Shimamura Joins the Marché du Film’s “Investors Circle 2026” as an Invited Investor, Backing a New Feature Film17.7.2026 03:00:00 CEST | Press release
Shimamura Yoshihiro Film Production Co., Ltd. (Head office: Osaka, Japan; Representative Director: Yoshihiro Shimamura), a company active in film production and investment, today announced that Representative Director Yoshihiro Shimamura has decided to invest in an international feature film after being invited to the “Investors Circle 2026” — a distinction that reflects his standing as one of the field’s most highly regarded producers and investors. Hosted by the Marché du Film, the business arm of the Festival de Cannes and one of the world’s largest film markets, the Investors Circle is an invitation-only summit that connects a select group of private investors with high-end feature films during early-stage financing. Held in Cannes, France, May 16-17, 2026, it brings internationally acclaimed directors and producers together with investors around a curated slate of projects in development. During the summit, Shimamura attended private pitching sessions and, after individual meeting
Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies17.7.2026 00:00:00 CEST | Press release
On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16 Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16 Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-
Merz Completes Inaugural €450 Million Schuldschein Loan Issuance16.7.2026 23:36:00 CEST | Press release
Debut transaction more than three times oversubscribed The Merz Group has successfully completed its first-ever Schuldschein loan issuance, placing a total volume of €450 million in the debt capital market – a multiple of three relating to the launch volume. The debut transaction was significantly oversubscribed and attracted strong interest from all investor groups. The proceeds were settled and paid out today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716926041/en/ Dr. Almuth Steinkühler, Chief Financial Officer Merz Group The transaction comprises both fixed- and floating-rate tranches with maturities of three, five, seven, and ten years. Around 50 German and international investors participated, representing a broad range of institutions, including private banks, German federal state-owned banks, public savings banks, cooperative banks, pension funds and occupational pension institutions. With the successful plac
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