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

Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Marketing Authorization Application to the European Medicines Agency (EMA) for MDS and Beta-Thalassemia26.4.2019 11:30:00 CESTPressemelding

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that Celgene has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts, require red blood cell (RBC) transfusions and have received or are not eligible for erythropoiesis-stimulating agents, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. Luspatercept is an investigational erythroid maturation agent that regulates late-stage red blood cell maturation. The safety and efficacy results provided in the application are from the pivotal phase 3 studies MEDALIST and BELIEVE, evaluating the ability of luspatercept to effectively address anemia associated with MDS and beta-thalassemia, respectively. “As a first-in-class erythroid maturation ag

SES: First Quarter 2019 Results26.4.2019 06:00:00 CESTPressemelding

SES S.A. announced its financial results for the three months ended 31 March 2019 with revenue and EBITDA in line with company expectations and SES on track to deliver on its 2019 financial outlook. Continued focus on execution has delivered major wins in the Networks business which is soon to be enhanced with the addition of four new O3b satellites, successfully launched at the beginning of April 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005955/en/ First Quarter 2019 Results Key financial highlights Reported revenue of EUR 480.6 million, (down 2.3% at constant FX(1)) in line with SES’ expectations Underlying revenue(2) of EUR 473.9 million; down 3.1%(1) (Video: -7.3%(1,2) and Networks +5.4%(1,2)) EBITDA of EUR 290.1 million representing a margin of 60.4% (Q1 2018: 63.7%); 62.1% excluding restructuring charge Net profit attributable to SES shareholders of EUR 72.2 million Free Cash Flow before financing acti

Wenco and Hitachi Construction Machinery Announce Open and Interoperable Partner Ecosystem for Autonomous Mining25.4.2019 23:30:00 CESTPressemelding

Hitachi Construction Machinery Co., Ltd. (TOKYO: 6305) (“HCM”) is pleased to announce its vision for autonomous mining — an open, interoperable ecosystem of partners that integrate their systems alongside existing mine infrastructure. Grounded in support for ISO Standards and a drive to encourage new entrants into the mining industry, HCM is pioneering this open and interoperable approach to autonomy among global mining technology leaders. With this announcement, HCM is publicly declaring support for standards-based autonomy and is offering its interoperable technology to assist mining customers in integrating new vendors into their existing infrastructure. HCM’s support for open, interoperable autonomy is based on its philosophy for its partner-focused Solution Linkage platform. “Open innovation is the guiding technological philosophy for Solution Linkage,” says Vice President and Executive Officer, Chief Technology Officer Hideshi Fukumoto. “Based on this philosophy, HCM is announcin

Garth Brooks Makes Mobile Game Debut in Words With Friends, Announces Final Pre-Order Window for The Legacy Collection25.4.2019 19:30:00 CESTPressemelding

Today, Zynga Inc. (Nasdaq: ZNGA), global leader in interactive entertainment, announced a collaboration with Garth Brooks, in its hit game, Words With Friends 2 . Kicking off a multi-month celebration of the game franchise’s 10th anniversary, and Brooks’ unprecedented career as a recording artist, players and fans will be treated to Garth-themed in-game activities and ongoing announcements starting with today’s reveal of ‘Journey’ as the game’s ‘Word of the Year’. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005903/en/ Garth Brooks LEGACY COLLECTION (Graphic: Business Wire) Garth Brooks and Words With Friends are celebrating their 2019 milestones by giving fans new ways to interact with Garth and the game. On May 1st, Brooks will co-host Words With Friends LIVE, the nightly trivia game broadcast within Words With Friends 2. In conjunction, the FINAL pre-order window for special numbered editions of The Legacy Collect

Nordson EFD Introduces the Contact versus Jet Dispensing White Paper25.4.2019 12:16:00 CESTPressemelding

Nordson EFD , a Nordson company (NASDAQ: NDSN), the world’s leading precision fluid dispensing systems manufacturer, is pleased to introduce its Contact vs. Jet Dispensing white paper. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005027/en/ As products continue to get smaller and smaller, Nordson EFD has developed new solutions to address this growing need to apply precise, repeatable micro-deposits of assembly fluids in production processes worldwide. “We understand the challenges manufacturers face when their process requires bonding tiny substrates and components together,” said Peter Langer, Business Unit Director of Valves at Nordson EFD. “The deposit tolerance requirements are considerable. And there are a number of variables to consider in order to choose the right dispensing method.” This white paper helps manufacturers understand the difference between two of the most common dispensing methods. Contact dispe

Hologic Launches Trident® HD Specimen Radiography System in United States, Canada and Europe25.4.2019 12:15:00 CESTPressemelding

Hologic, Inc. (Nasdaq: HOLX) today announced global commercial availability of the Trident® HD specimen radiography system, a next-generation solution that delivers enhanced image quality, improved workflow and instant sample verification during breast-conserving surgeries and stereotactic breast biopsies.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005180/en/ Trident® HD Specimen Radiography System (Photo: Business Wire) The Trident products are the only specimen radiographs on the market to use amorphous selenium direct capture imaging – the same detector technology used in Hologic’s 3Dimensions™ mammography system – to generate crisp, clear, high-resolution images. The new Trident HD system, which recently received FDA clearance in the US and a CE Mark in Europe, also features a bigger detector that allows for complete imaging of larger breast surgical specimens, along with a wide range of surgical and biopsy sa