Business Wire

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

Del

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.

About Kite

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.

Forward-Looking Statements

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.

Contact information

Gilead Sciences, Inc.
Sung Lee, +1-650-524-7792
Investors
or
Nathan Kaiser, +1-650-522-1853
Media (U.S.)
or
Sarah Swift, +44 (208) 587-2618
Media (Europe)

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Bank of America Reports Fourth-Quarter 2018 Financial Results16.1.2019 11:45Pressemelding

Bank of America reported its fourth-quarter 2018 financial results today. The news release, supplemental filing and investor presentation can be accessed in the following ways: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005355/en/ Bank of America newsroom at https://newsroom.bankofamerica.com Bank of America Investor Relations website at http://investor.bankofamerica.com Business Wire’s news webpage at http://www.businesswire.com/portal/site/home/news Investor Conference Call information Chief Executive Officer Brian Moynihan and Chief Financial Officer Paul Donofrio will discuss the financial results in a conference call at 8 a.m. ET today. For a listen-only connection to the conference call, dial 1.877.200.4456 (U.S.) or 1.785.424.1732 (international). The conference ID is 79795. Please dial in 10 minutes prior to the start of the call. Investors can also listen to a live audio webcast of the conference call and

Eurosport Signs an Exclusive Multi-Year Partnership Deal with Outbrain, Which Includes Outbrain’s Smartfeed and Video Technology16.1.2019 11:00Pressemelding

Outbrain, the world’s leading native advertising platform, announced today it has signed a pan-regional deal with Eurosport, the number one destination for sports fans. The agreement spans 13 markets globally, including the UK, France, Germany, Italy, Spain, Asia, and Australia, and will be powered by Outbrain’s innovative Smartfeed technology. Smartfeed provides a content discovery feed that allows publishers to customise the user experience, improving both engagement and revenue. It is designed for a range of content from promoted articles to editorial pieces to videos, and functions across all devices including desktop, mobile, and apps. Eurosport will also utilise Outbrain’s Amplify platform to promote their own videos. Earlier this year, Outbrain released Focus, a click-to-watch video experience built for engagement and performance, and tailored for high quality and long form video content. Focus consistently results in higher click-through and completion rates, which makes it ide

Knopp Biosciences Expands Research Collaboration with Cincinnati Children’s to Characterize Effect of Dexpramipexole in Inflammatory Diseases16.1.2019 11:00Pressemelding

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases with a high unmet need, today announced the expansion of its research collaboration with Cincinnati Children’s Hospital Medical Center to further elucidate the eosinophil-depleting mechanism of action of Knopp’s lead investigational drug, dexpramipexole. Eosinophils are white-blood cells that play a central role in several debilitating conditions, including asthma, hypereosinophilic syndrome (HES), and other inflammatory diseases. Dexpramipexole has been shown to selectively reduce eosinophil levels in multiple clinical trials, including a Phase 2 study in HES and a Phase 2 trial in chronic rhinosinusitis with nasal polyps. Knopp is advancing dexpramipexole into Phase 2 development in severe asthma and Phase 3 development in HES. The research at Cincinnati Children’s Hospital Medical Center is being led by Patricia C. Fu

NexPlayer Supporting Low Latency HLS & DASH Streaming on Android, iOS, Smart TVs, STBs, PCs, and Macs16.1.2019 09:52Pressemelding

As part of their mission to provide the most advanced feature set, NexPlayer has added low latency functionality to its media players. NexPlayer allows you to enable low latency streaming with HLS and DASH on all devices, solving the latency problem and improving the OTT viewing experience. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005301/en/ Latency is a serious issue for streaming services, as live playback with HLS and DASH typically falls 30 seconds to a minute behind the live event. With linear TV only 6 seconds behind, OTT viewers find out what happens via social media or text before seeing it firsthand. Now with the support of NexPlayer, media organizations can achieve sub-6 second latency on Android, iOS, Smart TVs, STBs, PCs, and Macs. In the past, the only ways to achieve low latency were through proprietary end-to-end protocols or by foregoing ABR support. Both methods have considerable drawbacks. Propr

Temenos Revolutionises its Banking Software, with the Launch of Two New Cloud-Native, Cloud-Agnostic Products – Temenos Infinity & Temenos T24 Transact to Accelerate Cloud Adoption16.1.2019 08:43Pressemelding

Temenos (SIX: TEMN) the banking software company, today marked a major milestone with the launch of two new products. Temenos Infinity – a breakthrough digital front office product and Temenos T24 Transact – the next generation in core banking. These new products combine the most complete banking functionality in the market, leveraging 25 years of functionality from 3,000 banks in over 150 countries with the most advanced cloud-native, cloud-agnostic, API first technology and design-led thinking. Through APIs, both products can be implemented independently or integrated. Clients will be able to roll-out new applications in hours utilising advanced continuous deployment tools and methodologies. The conversion from Temenos’ existing Digital Front Office and T24 Core Banking products are automatic and upgrades for existing clients to the new cloud-native, cloud-agnostic Temenos products are available from April 2019. All Temenos SaaS products run on the new Temenos platform. Temenos Infin

Urban Airship Acquires Accengage, Extending Its Worldwide Leadership with Unmatched Presence Across Europe16.1.2019 08:30Pressemelding

Digital customer engagement company Urban Airship today announced that it has acquired Accengage, continental Europe’s largest provider of mobile CRM and push notifications. Together Urban Airship and Accengage now form the world’s largest mobile customer engagement company, with rapidly growing solutions for apps, websites, SMS, email, mobile wallets and other channels. Customers from each company will quickly benefit from access to new technology and expanded engineering resources, as well as support from Europe’s largest team of digital customer engagement experts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190116005215/en/ Urban Airship customers include 25 percent of the Fortune 100 with companies such as Adidas, ASOS, BBC, Caesars Entertainment, Jet Airways, Shop Direct, Vodafone and Zeit Online. Accengage adds hundreds more global brands including Air France-KLM, Lidl, Mediaset España, OUI.sncf, Orange, Sephora Eu