Business Wire

European CHMP Adopts Positive Opinion for Yescarta® (axicabtagene ciloleucel) 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 Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the company’s Marketing Authorization Application (MAA) 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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180629005318/en/

Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T) therapy that modifies a patient’s own T cells to recognize and attack cancer cells and has the potential to induce complete responses (no detectable cancer) in a proportion of patients with aggressive forms of non-Hodgkin lymphoma (NHL). Axicabtagene ciloleucel was granted PRIME status by the EMA in May 2016.

The CHMP positive opinion was adopted following review by European Union (EU) regulators, including the Committee for Advanced Therapies and the CHMP. The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the EU, Norway, Iceland and Liechtenstein.

“This CHMP positive opinion is an important milestone for those patients in the European Union living with DLBCL or PMBCL,” said Alessandro Riva, MD, Gilead’s Executive Vice President, Oncology Therapeutics & Head, Cell Therapy. “The recommendation brings axicabtagene ciloleucel one step closer to adult patients who currently have few or no treatment options available to them and we are focused on providing access to this innovative treatment as quickly as possible.”

The 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). Grade 3 or higher adverse events reported during ZUMA-1 included, but were not restricted to, cytokine release syndrome (CRS), neurologic events and cytopenias.

DLBCL is the most common form of NHL and represents an area of significant unmet need. The prognosis for patients with refractory DLBCL is very poor, with a median survival of just six months. Across the EU in 2018, there are an estimated 7,700 patients with DLBCL who are refractory to, or have relapsed after, two or more lines of therapy, and may be eligible for CAR T therapy.

Axicabtagene ciloleucel was approved by the U.S. Food and Drug Administration on October 18, 2017. In the EU, axicabtagene ciloleucel is an investigational product and its efficacy and safety have not been established.

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 the European Commission may not approve axicabtagene ciloleucel in the currently anticipated timelines or at all, and any marketing approval, if granted, may have significant limitations on its use. 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 March 31, 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.

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

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

Highlights of China’s No. 1 High-Tech Fair CHTF 201815.11.2018 02:00Pressemelding

The 20th China Hi-Tech Fair (CHTF 2018) is being held from November 14-18 at the Shenzhen Convention and Exhibition Center with the theme “New Development Concept for High Quality Growth.” This year’s CHTF consists of exhibitions, forums, professional meetings, supporting activities, talents exchange meetings and overseas fairs, and features advanced manufacturing, next-generation information technology, AI, life sciences, new materials, new energy, as well as integration of real economy and future industries. Here are some of the highlights of CHTF 2018: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005654/en/ International and Belt & Road Pavilion of CHTF (Photo: Business Wire) Themed areas focusing on industry hotspots The IT exhibition will present themed areas like AI, smart manufacturing, smart automotive, sports technology, big data, cloud computing, IoT and blockchain; the environmental exhibition will highlig

MapleStory Prepares for Epic Battle Against the Black Mage in Gathering of Heroes Event14.11.2018 21:00Pressemelding

MapleStory, the iconic global MMORPG from Nexon America, is bringing the first phase of its long-awaited battle with the sinister villain, the Black Mage. Between November 14 through November 28, players can take part in the “Gathering of Heroes” event to join the Maple Alliance and prepare their armies to soon combat the Black Mage. The Black Mage has long been the main antagonist behind MapleStory. His story originated with the role of bringing balance to Maple World, but turned dark as he realized the only way to save Maple World was to destroy it. Now that his seal has been broken, players will need to work together to defeat the legendary boss. The Gathering of Heroes event adds the Maple Alliance outpost, where players can hone their skills and prepare to level up in preparation of for their battle against the Black Mage, as well as adds various leveling updates. The main goal of the Alliance is to gather “Determination” and power up the holy light in the outpost to be able to fi

SpinalCyte Announces Sustained 12-Month MRI Outcomes After CybroCell™ Injection14.11.2018 20:07Pressemelding

SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced that a single injection of modified human dermal fibroblasts (HDFs), resulted in significant improvements of disc height and pain reduction 12 months after injection of the cell therapy for patients with degenerative disc disease (DDD). The trial assessed patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and disc height via MRI scans. Using composite scoring, 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). Over 84% of patients in the treatment group of CybroCell™ or CybroCell™ with platelet rich plasma (PRP) injections had an increase or no change in disc height compared to 25% for the placebo saline injection. Analyzed individually, 83% of spinal discs that were injected with CybroCell™ had an increase or no change in disc he

Raising Awareness about Early Onset Dementia: “Don’t Leave me now”, Written by Brian Daniels14.11.2018 16:55Pressemelding

The Fondation IPSEN is delighted to invite you to a theatre performance about familial upheavals when a family member is affected by Alzheimer’s disease or cerebral dementia (November 21 st at 4pm). This play has been written by playwright Brian Daniels and directed by Jeni Draper, has had more than 200 performances and explores with insight and humour the impact of early onset dementia on family life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005695/en/ (Graphic: Business Wire) Free entrance, but registration is mandatory (limited seats): Please click here NOVEMBER 21 st , 4 pm “Le Petit Théâtre de la Fondation IPSEN” 65 quai George Gorse 92150 Boulogne-Billancourt (Metro Line 9, Pont-de-Sèvres) About the Project Our “Science for People” program is composed of accessible meetings and webinars to improve access to science. Brian Daniels’ play “Don’t leave me now” is about caregivers of people with Alzheimer’s Dise

HCL Technologies Celebrates 10 Years of Success in the Nordics14.11.2018 16:44Pressemelding

HCL Technologies (HCL), a leading global technology company, is celebrating its 10-year anniversary in the Nordic region. During this time, the company has achieved significant successes, which have seen the Nordics grow to become HCL’s largest market in Europe. Today, HCL employs more than 1,600 people in the Nordics representing 31 nationalities, with 55 large-scale transformational clients including four out of the six Fortune Global 500 companies in the region. While several significant milestones have been successfully achieved, HCL looks forward to the future and is dedicated to helping its clients in the Nordics to drive innovation and growth. The celebration coincides with a series of initiatives to mark this occasion starting with the opening of a new office at HCL’s Nordics headquarters in Central Stockholm. “We are humbled by the success that we have achieved together with our clients, colleagues and partners in the Nordics,” said Pankaj Tagra, EVP Nordic and DACH Head, HCL

The Next Industrial Transformation is Here: Rockwell Automation is Helping Businesses Prepare to Succeed at Automation Fair 201814.11.2018 16:35Pressemelding

Today, at its annual Automation Fair, Rockwell Automation unveiled its new brand promise: Expanding Human Possibility by combining the imaginations of people with the intelligence of machines. The brand promise supports the company’s emphasis on bringing The Connected Enterprise to life and how, by linking people, machines and data across an entire business, manufacturers become more effective and productive. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181114005671/en/ Blake Moret, chairman and CEO, Rockwell Automation, shares his vision for bringing the Connected Enterprise to life and how manufacturers can expand human possibility by linking people, machines and data across their businesses, helping them to become more effective and productive. (Photo: Business Wire) “The new Rockwell Automation brand emphasizes the central role that people play in advanced manufacturing and underscores our focus on ways we maximize per