EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer
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 deruxtecanis 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 deruxtecanmonotherapy 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 :
1Iqbal N, et al. Mol Biol Int. 2014; 2014: 852748
2Tandon A, et al. J Clin Oncol. 1989;7(8):1120-8.
3Sledge G, et al. J Clin Oncol. 2014;32(19):1979-1986.
4de Melo Gagliato D, et al. Oncotarget. 2016;7(39):64431-46.
5National 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/
Contact information
Global/US:
Jennifer Brennan
Daiichi Sankyo, Inc.
jbrennan2@dsi.com
+1 908 992 6631 (office)
+1 201 709 9309 (mobile)
EU:
Lydia Worms
Daiichi Sankyo Europe GmbH
lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)
+49 176 11780861 (mobile)
Japan:
Masashi Kawase
Daiichi Sankyo Co., Ltd.
kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
About Business Wire
Business Wire(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CEST | Press release
Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China
U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 12:15:00 CEST | Press release
Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th
Palladio Completes $20 Million Series B Financing25.9.2020 12:09:00 CEST | Press release
Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp
Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 09:54:00 CEST | Press release
Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k
Deloitte Launches < "The Next Wave" Emerging Digital Life in South and Southeast Asia > Report At Ant Group’s INCLUSION Fintech Conference25.9.2020 07:55:00 CEST | Press release
Deloitte launched <"The Next Wave" Emerging Digital Life in South and Southeast Asia > Report today at the INCLUSION Fintech Conference, organized by Ant Group and Alipay to foster a global dialogue on building a more inclusive, green, and sustainable world through digital technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005941/en/ (Graphic: Business Wire) Through an extensive survey conducted across age groups in eight countries in South and Southeast Asia, specifically Singapore, Malaysia, Thailand, Indonesia, the Philippines, India, Bangladesh and Pakistan, the report showed that consumers aged between 21 and 40 years old are the leading force enabling the rapid adoption of a digital life in the region in the post Covid-19 world. Speaking at one of the media forums on Day 2 of INCLUSION, Taylor Lam, Technology, Media & Telecommunications Industry Leader at Deloitte China, said: “Young and vibrant economies
Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 07:00:00 CEST | Press release
Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm