Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy
Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission (EC) has granted Marketing Authorization for Yescarta® (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. The Marketing Authorization approves axicabtagene ciloleucel for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180827005248/en/
Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy, which harnesses a patient’s own immune system to fight certain types of blood cancer. The cell therapy has been proven to induce complete response (no detectable cancer) in a proportion of patients with relapsed or refractory DLBCL and PMBCL, which are aggressive forms of non-Hodgkin lymphoma (NHL).
“Axicabtagene ciloleucel is a new and exciting way of treating cancer that offers a new option to patients with DLBCL and PMBCL in Europe,” said Professor Gilles Salles, Head of Hematology, South Lyon Hospital Complex. “Many patients with these aggressive forms of non-Hodgkin lymphoma who have not responded to or failed commonly available treatment options have a very poor prognosis and there is an urgent need for new therapies.”
The Marketing Authorization Application (MAA) is supported by data from the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with refractory aggressive NHL. In the single-arm trial, 72 percent of patients (n=73/101) who received a single infusion of axicabtagene ciloleucel responded to therapy, with 51 percent (n=52/101) achieving a complete response (as assessed by an independent review committee, median follow-up of 15.1 months). At one year following infusion, 60 percent of patients were alive (95% CI: 50.2, 69.2) and the median overall survival (OS) had not been reached (95% CI: not estimable [NE]).
Axicabtagene ciloleucel may cause side effects that are severe or life threatening, such as cytokine release syndrome (CRS) or neurological toxicities. In ZUMA-1, 12 percent of patients experienced Grade 3 or higher CRS and 31 percent experienced Grade 3 or higher neurologic toxicities. Overall 98 percent of patients recovered from CRS and/or neurologic adverse reactions. Treatment algorithms have been developed to manage some of the symptoms associated with both CRS and neurologic adverse reactions experienced by patients on axicabtagene ciloleucel.
The most common Grade 3 or higher adverse reactions include encephalopathy, unspecified pathogen infection, CRS, bacterial infection, aphasia, viral infection, delirium, hypotension and hypertension.
For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management) please refer to the EU Summary of Product Characteristics (SmPC).
“We are proud to be leading this frontier of cancer innovation that is bringing novel, personalized therapy to people living with these blood cancers,” said Alessandro Riva, MD, Gilead's Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “Our vision is for cell therapy to serve as the foundation for treating all cancer types. Today’s milestone is another step on this exciting and important journey.”
Axicabtagene ciloleucel was approved by the U.S. Food and Drug Administration on October 18, 2017.
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing axicabtagene ciloleucel for the treatment of DLBCL and PMBCL and the possibility of unfavorable results from additional clinical trials involving axicabtagene ciloleucel. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.
Full European Summary of Product Characteristics for Yescarta ® is available from the EMA website at www.ema.europa.eu .
Yescarta is a registered trademark of Gilead Sciences, Inc., or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com . Learn more about Gilead at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Sung Lee, +1-650-524-7792
Nathan Kaiser, +1-650-522-1853
Sarah Swift, +44 (208) 587-2618
About 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
Puma Biotechnology and Pierre Fabre Amend NERLYNX® License Agreement to Include Greater China25.2.2021 22:07:00 CET | Press release
Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, and Pierre Fabre, a leading French pharmaceutical company, have agreed to extend the terms of the 2019 license agreement which grants Pierre Fabre exclusive rights to develop and commercialize NERLYNX® (neratinib) within Europe, Turkey, Middle East and Africa. The amended agreement extends Pierre Fabre’s commercial rights for NERLYNX to Greater China, which includes mainland China, Taiwan, Hong Kong and Macau. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225006150/en/ Under the terms of the amendment, Puma will receive an upfront payment of $50 million, as well as additional regulatory and sales-based milestone payments that could add up to an additional $240 million. These milestones will be based solely on regulatory and sales achievements in Greater China. In addition, Puma will receive significant double-digit tiered royalties on the sales of NERL
Moody’s ESG Solutions Group: V.E Provides Second Party Opinion on Italy’s First Sovereign Green Bond Framework and Issuance25.2.2021 20:33:00 CET | Press release
Moody’s ESG Solutions Group announced today that Moody’s affiliate V.E has provided a Second Party Opinion on Italy’s sovereign green bond framework and first green bond issuance. The framework, which is aligned with the four core components of the Green Bond Principles 2018, will be used to finance budget lines reflective of Italy’s environmental priorities, including renewable energy and clean transportation. In V.E’s opinion, these categories are likely to contribute to seven of the United Nations Sustainable Development Goals. “In our assessment, the bonds issued via this framework will provide a ‘robust’ contribution to sustainability. Italy has committed to conduct due diligence on the environmental contribution of the projects that it chooses to finance. The financed expenses have clear benefits in terms of climate mitigation, climate adaptation, pollution prevention and control, transition to a circular economy, the responsible management of natural resources, and the protectio
International Zinc Association Launches Zinc Battery Initiative25.2.2021 19:48:00 CET | Press release
The International Zinc Association (IZA) is excited to announce the launch of its newest program, the Zinc Battery Initiative. Recent extreme weather events, amplified by climate change, have once again focused attention on the future role of fossil fuels and the capacity and resilience of energy grids worldwide. One of the most impactful ways of addressing this is through cost-effective energy storage. As renewables become an ever-greater part of the electrical grid, energy storage can help address solar and wind power's intermittency. It can also help respond to large fluctuations in demand by capturing and storing excess energy during low demand and bringing it online during peak times. Energy storage also helps provide resilience by serving as a backup energy supply when generation is interrupted. It will also play a pivotal role in electrifying transport, and other applications where power is needed, but tethered connections to the grid are not practical. Addressing climate change
Hyosung TNS Invites Customers to ‘Be Inspired’ With New Campaign25.2.2021 17:00:00 CET | Press release
Hyosung TNS, the world-leading ATM manufacturer, has begun a global initiative to reinvent its user experience through the implementation of a branding refresh titled “Be Inspired.” The campaign draws upon the impressive technological history of the industry innovator to lead clients through a journey to experience solutions-driven communication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005240/en/ Hyosung TNS' technologically impressive, new 140-page website has been designed to unify Hysoung's leadership in the financial institution and retail industries and consolidate all of its previous, regional websites into one global website, including a multi-language interface and an intuitive, interactive product catalog. (Photo: Business Wire) The “Be Inspired” initiative employs “plain language and interaction” that show how Hyosung is inspired by its customers to create new business solutions – and how those solutio
MyHeritage lanserer en banebrytende funksjon for å animere ansiktene i stillbilder25.2.2021 16:49:00 CET | Pressemelding
MyHeritage er verdens største globale tjenesten for å oppdage din fortid og styrke din fremtid. I dag annonserer selskapet Deep Nostalgia™, det en ny fotofunksjon som animerer ansikter i stillbilder. Deep Nostalgia™ gir slektshistorie et nytt perspektiv ved å produsere realistiske skildringer av hvordan mennesker kunne ha beveget seg og sett ut, hvis de hadde blitt videofilmet. MyHeritage er det eneste selskapet som tilbyr en komplett pakke med funksjoner for å fargelegge, gjenopprette, forbedre og nå animere historiske bilder. Denne pressemeldingen inneholder multimedia. Se hele pressemeldingen her: https://www.businesswire.com/news/home/20210225005805/no/ Introducing Deep Nostalgia™ (Photo: Business Wire) Denne teknologien som animerer ansikter i bilder ble lisensiert av MyHeritage fra D-ID, som er et selskap som har spesialisert seg på videorekonstruksjon ved hjelp av dyp læringteknologi. Deep Nostalgia™ bruker flere forhåndsdefinerte beveglsesvideoer som er utarbeidet av MyHeritage
CMT’s New Report Confirms Increasing Appetite for Connected Insurance in Europe25.2.2021 16:25:00 CET | Press release
A large shift in driving habits due to the COVID-19 pandemic has changed how people think about motor insurance across Europe, according to a new study by Cambridge Mobile Telematics (CMT), the world’s leading mobile telematics and analytics provider. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005773/en/ (Graphic: Business Wire) Based on the surveys of 4,000 drivers in France, Germany, Italy and the U.K., the new report shows shifting attitudes towards quoting channels, claims services, pricing models and value-added services, broken down and analysed by location, age and driving behaviour. The two surveys - taken in January 2020, before the pandemic, and then nine months later in September 2020 - reveal up to 81 percent of the drivers in Europe have changed how they drive because of COVID-19. Now 65 percent are interested in connected insurance, a 32% jump in nine months. The pandemic has modified commuting patter
Alpega Group Showed Impressive Results In 202025.2.2021 16:00:00 CET | Press release
Alpega Group, a leading provider of end-to-end transportation and logistics management software, has positioned itself to meet logistics challenges with impressive results in 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210225005665/en/ Alpega Group, a leading provider of end-to-end transportation and logistics management software, has positioned itself to meet logistics challenges with impressive results in 2020. (Photo: Alpega Group) Alpega’s business units had an outstanding performance last year. On one hand, their freight exchanges’ customer acquisitions strongly grew by 20% compared to the previous year and existing clients had a higher renewal rate. On the other hand Alpega TMS added 83 new customers and had a tremendous increase in usage of their smart booking solution. Alpega’s CEO, Todd DeLaughter, commented on these results: “I’m very excited with Alpega’s excellent performance proving the value of our sol