Kite Files the Industry’s First CAR-T Marketing Authorization Application in Europe for Axicabtagene Ciloleucel
Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant. This application represents the first chimeric antigen receptor (CAR) T-cell therapy submitted to the EMA. Axicabtagene ciloleucel is currently under review by the U.S. Food and Drug Administration (FDA), and the FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2017.
The MAA for axicabtagene ciloleucel is supported by data from the ZUMA-1 trial, which met the primary endpoint of objective response rate (ORR), with 82 percent (p < 0.0001) of patients achieving a response after a single infusion of axicabtagene ciloleucel. At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR). The most common Grade 3 or higher adverse events included cytokine release syndrome and neurologic events, which were generally reversible.
“The MAA submission of axicabtagene ciloleucel marks an important global milestone in the development of engineered T cell therapy,” said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. “We are excited to work closely with the EMA, Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to help bring this potentially transformative therapy to patients in the EU.”
Non-Hodgkin lymphoma (NHL) is a type of blood cancer that affects around 93,000 people in Europe every year.i DLBCL is one of the subtypes of NHL that is aggressive or fast growing.ii While many patients can achieve and maintain complete remission after initial treatment, patients who experience relapse or do not respond to initial treatment historically have poor outcomes. The company estimates that approximately 7,800 patients in the EU 5 alone may benefit from CAR-T therapy.
In May 2016, the CHMP and CAT granted access to its newly established Priority Medicines (PRIME) regulatory initiative for axicabtagene ciloleucel in the treatment of patients with refractory DLBCL. Access to the PRIME initiative is granted by the EMA to support the development and accelerate the review of new therapies to treat patients with a high unmet need.
About axicabtagene ciloleucel
Kite's lead product candidate, axicabtagene ciloleucel, is an investigational therapy in which a patient's T cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Axicabtagene ciloleucel has been granted Breakthrough Therapy Designation status for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of axicabtagene ciloleucel, and the ability to obtain EMA approval for axicabtagene ciloleucel. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended March 31, 2017. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Kite assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
i Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, et al.
Cancer incidence and mortality patterns in Europe: Estimates for 40
countries in 2012. European Journal of Cancer 2013;49:1374-1403.
ii Non-Hodgkin Lymphoma (NHL). “NHL Subtypes” Leukemia & Lymphoma Society. http://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes [Last accessed July 20, 2017].
Om Business Wire
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
Wealth Dynamix (WDX) Ranks No.18 in the 2017 Tech Track 100 by the Sunday Times and 19th Fastest Growing Technology Company in the UK in the 2017 Deloitte Technology Fast 5023.11.2017 08:00 | Pressemelding
WDX ranks No.18 in the 17th annual Sunday Times Hiscox Tech Track 100 league table league which consisted of the top 100 private technology, media and telecoms (TMT) companies in Britain. WDX recorded a 155% average annual sales growth per year over the last 3 years with sales reaching £6.4M in September 2016 and £9m by end of September 2017. More recently, in November 2017, WDX also announces ranking No.19 in the 2017 Deloitte UK Technology Fast 50, a ranking of the 50 fastest growing technology companies in the UK. Rankings are based on percentage revenue growth over the last four years of which, WDX grew 1,563% during this period. WDX attributed this revenue growth to the team’s hard work and the positive change in attitude toward technology in the Wealth and Investment Management industry. WDX’s CEO, Gary Linieres credits the team with the company’s revenue growth. He sa
Mobidiag Signs Agreement with Interlux for the Distribution of Amplidiag® Diagnostic Tests and Instruments in Estonia23.11.2017 07:00 | Pressemelding
Mobidiag Ltd, a Finnish molecular diagnostics company, today announced a distribution agreement with Interlux OÜ, supplier of technologies for medicine, science and biotechnology industry. Under this agreement, Interlux becomes the exclusive distributor of the Amplidiag® product line in Estonia, in vitro diagnostic tests and compatible instrument for the detection of gastrointestinal infections. “Thanks to a large distribution network, our Amplidiag product line is now accessible in most Western European countries. This new distribution agreement allows us to introduce the Amplidiag product line to the Baltic region starting with Estonia. We are then very happy to start this new partnership with Interlux to support us in this new market”, said Miquel Vernet, CCO at Mobidiag. “Cooperation with Mobidiag offers the customers of Interlux high-quality diagnostic results. I believ
OCP Announces Date of 2017 Third Quarter and Nine Month Results22.11.2017 16:59 | Pressemelding
OCP S.A., a global leader in the fertilizer industry, will release its third quarter and nine month 2017 results on Thursday, November 30, 2017. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal at 9 a.m. EDT and 2 p.m. Morocco/London time. OCP senior management will host a conference call to discuss 2017 third quarter/nine month results at 10 a.m. EDT and 3 p.m. Morocco/London time on Thursday, November 30, 2017 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing email@example.com. About OCP OCP is a global leader in the fert
Tata Motors Charts Out 'Connecting Aspirations' As Its New Corporate Brand Identity in Global Markets22.11.2017 14:46 | Pressemelding
As part of the company’s transformation journey undertaken in 2016, Tata Motors commenced a comprehensive project to articulate its corporate branding. Basis a thorough analysis of the existing and the desired future state of the Company, Tata Motors has defined its new brand identity as ‘Connecting Aspirations’ across 46 markets, internationally. ‘Connecting Aspirations’, as the new defining maxim, represents the personality of the brand as an interconnected system of mobility solutions, that are intelligent, perceptive, warm and expressive. It’s a symbolic tagline that represents the company’s past, present and future. It is humble yet bold, a statement as well as a challenge. It will define the way Tata Motors communicates with its internal as well as external stakeholders, and work as an all-encompassing guiding principle across business units.” Speaking on the
NelsonHall Positions L&T Technology Services in the Leaders Category for IoT Services22.11.2017 13:50 | Pressemelding
L&T Technology Services Limited (NSE: LTTS), a leading global pure-play engineering services company announced that it has been positioned in the Leaders Category by independent global research firm, NelsonHall in its latest NEAT evaluation for Internet of Things (IoT) services providers. LTTS is the only global pure-play engineering services to be positioned in the leader’s category. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171122005331/en/ L&T Technology Services Capabilities across IoT Services. (Graphic: Business Wire) LTTS has been identified as a leader relative to its peers’ due to its ability to meet future client requirements as well as deliver immediate benefits to IoT Services clients. Dominique Raviart, IT Services Practice Director, NelsonHall said, “L&T Technol
Smithers Viscient Europe Appoints Alasdair Clipston Director of Chemistry.22.11.2017 10:30 | Pressemelding
Smithers Viscient, a global contract research organisation (CRO), announced the appointment of Alasdair Clipston to the role of Director of Chemistry. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171122005035/en/ Smithers Viscient Europe Appoints Alasdair Clipston Director of Chemistry. (Photo: Business Wire) Clipston joins Smithers with 15 years spent within contract research and testing organisations including AstraZeneca and Charles River. “Alasdair brings great knowledge and experience to our operational leadership team, particularly in residue and physical chemistry including five batch analysis.” said Steve Dean, Managing Director, Smithers Viscient Europe. Dean continues, “His skills and passion for science coupled with excellent client relationships and strong business unde
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom