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
Om 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.
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
IFF Announces Pricing of $1,500,000,000 Senior Notes Offering24.9.2018 22:25 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF), a leading innovator of sensorial experiences that move the world, today announced that it has priced its public offering of $300,000,000 aggregate principal amount of its 3.400% senior notes due 2020, $400,000,000 aggregate principal amount of its 4.450% senior notes due 2028 and $800,000,000 aggregate principal amount of its 5.000% senior notes due 2048. IFF intends to use the net proceeds from the offering to pay a portion of the consideration for the previously announced merger with Frutarom Industries Ltd. and to pay related fees and expenses. IFF anticipates that the offering will close on September 26, 2018, subject to customary closing conditions. The offering is not contingent upon the consummation of the merger. If the closing of the merger has not occurred on or prior to February 7, 2019, or, if prior to such date, the merger agreement with Frutarom is terminated, IFF will be required t
Iberdrola Recognized as United Nations Global Compact LEAD24.9.2018 21:12 | Pressemelding
Today, Iberdrola, one of the world’s largest utilities and the leading renewable energy producer, is pleased to announce that the Company has been recognized as Global Compact LEAD for demonstrating its ongoing commitment to the United Nations Global Compact and its Ten Principles for responsible business. Announced at UN Headquarters in New York during the UN Global Compact Leaders Summit 2018, Iberdrola was identified as being among the highest-engaged participants of the world’s largest corporate sustainability initiative. Lise Kingo, CEO and Executive Director of the UN Global Compact, said, “LEAD companies represent the highest level of engagement with the UN Global Compact. Achieving the Sustainable Development Goals and creating the world we want will not happen without bold action from the responsible business community. We need companies of all sizes — like the ones recognized today — to improve their performance, no matter where they are on their sustainability journey.” “Sin
Pre-Registration for MapleStory 2 Starts Today24.9.2018 17:00 | Pressemelding
Pre-registration for MapleStory 2, the newest MMORPG adventure in Maple World, is available starting today. From September 24 through October 8, players can sign-up on the MapleStory 2 Pre-Registration site available here and earn exclusive rewards! Pre-registration web rewards will include unique in-game items such as the Roosting Seagull, Rustic Mushcabin Name Tag, and the Dusty Rickshaw. From September 24 through October 8, players can also receive a Mint Body Pillow by retweeting the new Runeblade trailer on Twitter and/or liking on Facebook. In addition to pre-registration, players who purchased a Founder’s Pack can jump into Head Start starting October 1, which will allow them to join MapleStory 2 's vibrant and immersive world ahead of global launch on October 10. Along with beta improvements, Head Start (October 1 - October 10) will include: Character progression that carries over to the official launch 6 character slots Founder’s Pack items Access to Gemstones Lv. 1 - 50 Quest
First Engineering Faculty in Canada Named after a Woman: Business Leader Gina Cody Makes Historic $15 Million Donation to Montreal’s Concordia University24.9.2018 15:15 | Pressemelding
Three decades after becoming the first woman to earn a PhD in building engineering from Concordia University, Gina Parvaneh Cody, MEng 81, PhD 89, has made history by giving $15 million to her alma mater. In recognition of her transformative gift to the “Campaign for Concordia: Next-Gen. Now”, the university has named its faculty of engineering and computer science after the alumna. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005425/en/ (Photo: Business Wire) The Gina Cody School of Engineering and Computer Science is the first engineering faculty in Canada — and one of the first internationally — to be named after a woman. Gina Cody, a top business leader and building engineer, credits much of her success to Concordia because the university provided her with an entrance scholarship. “I arrived in Canada as a young student from Iran in 1979 with $2,000,” she says. “Concordia welcomed me and provided me with support
Dole’s Standard Fruit Celebrates 20-Year Milestone as Environmental Leader24.9.2018 15:00 | Pressemelding
Earlier in September Dole Food Company participated in a celebration of the twentieth anniversary of the company’s initial receipt of its ISO 14001 Certification. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005079/en/ Dole Fresh Fruit President Renato Acuña speaks at the anniversary celebration of Dole's landmark environmental sustainability certification. (Photo: Business Wire) On July 2, 1998, Standard Fruit Company of Costa Rica S.A., a subsidiary of Dole Food Company, Inc., became the first agricultural and banana company in the world to receive the globally recognized ISO 14001 Certification for its environmental management policy and the establishment of its Integrated Management System. With the certification, the company further strengthened its robust Environmental Management System, with results that place it at the forefront in the sustainable production of bananas and pineapples. The celebration event, h
Helsinki Joins New York in Commitment to Review Local Progress Toward Global Sustainable Development Goals24.9.2018 14:42 | Pressemelding
In July 2018, the City of New York became the first city in the world to submit to the United Nations its progress toward the Sustainable Development Goals (SDG’s) on city level. As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180924005633/en/ As the first European city Helsinki will follow New York City and become the second city in the world in effort to showcase crucial role of cities in achieving UN agenda for people, prosperity and planet. Photo: Jussi Hellsten The Mayor of Helsinki Jan Vapaavuori announced Helsinki’s commitment to the voluntary local review at a panel conversation with New York City’s Commissioner of International Affairs Penny Abeywardena at the Social Good Summit in New York City on Sunday. Even thou