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].
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
DoubleTree by Hilton Closes Out Milestone Year with 30+ New Hotels, 510 Hotels Worldwide14.12.2017 16:01 | Tiedote
2017 was a monumental year for DoubleTree by Hilton, one of Hilton’s (NYSE: HLT) 14 market-leading brands, surpassing 500 hotels worldwide and introducing 30+ new hotels to guests around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171214005385/en/ DoubleTree by Hilton Dubai - Business Bay (Photo: DoubleTree by Hilton) To close out the year, the brand recently welcomed an additional three hotels to its portfolio. With convenient locations, inspired design and thoughtful upscale amenities, these hotels are now delivering unparalleled hospitality to guests and visitors, all starting with the brand’s signature, warm DoubleTree Cookie welcome. DoubleTree by Hilton Neenah : This contemporary hotel, which recently completed a multimillion
Dole Pineapple Workers Open Community Center Thanks to Fair Trade14.12.2017 16:00 | Tiedote
Dole Food Company and Fair Trade USA jointly announced today the inauguration of two new community centers near Dole’s Muelle and Bosque Farms in Costa Rica, made possible by Fair Trade purchases made at Whole Foods Market stores, which drive additional money to pineapple farmworkers to invest in projects of their choosing. The commencement events at the two locations took place on December 5th and 6th, 2017. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171214005458/en/ (Photo: Business Wire) To earn Fair Trade certification, farms must adhere to rigorous social, environmental and economic standards. Once certified, farmworkers directly earn additional Community Development Funds with every purchase. They then vote on how to use the money to address their needs. This direct economic be
Reply: Go Reply Becomes a Google Cloud Managed Service Provider14.12.2017 16:00 | Tiedote
Go Reply, the Reply Group company specialising in innovative Cloud services based on Google Cloud technology, has become a Google Cloud Managed Service Provider (MSP), joining a group of highly specialized Google Cloud partners. Go Reply supports customers through the whole cloud journey, able to respond to business needs during the different phases of the process, from engagement, to migration and execution, to post planning with optimization after deployment. As a Google Cloud MSP, Go Reply provides a high-touch service to customers who are looking for a complete and proactive support. Go Reply is able to bundle exclusive services for enterprise customers, covering not only the Cloud migration, but also all the aspects of the process, including future developments. Go Reply has access to Google training programs, Google Professional Services, and Google S
21st Century Fox to Spin off Businesses and Create New “Fox”; a Growth Company Centered on Live News and Sports Brands and the Iconic Fox Brand14.12.2017 15:12 | Tiedote
Twenty-First Century Fox, Inc. (“21st Century Fox” or the “Company” – NASDAQ: FOXA, FOX) today announced that it intends to spin off to 21st Century Fox shareholders a portfolio of its highly-rated news, sports and broadcast businesses to create a new “Fox,” which will be a growth company centered on live news and sports brands, anchored by the strength of the Fox Network. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171214005660/en/ Left to right: Robert A. Iger, Chairman and CEO of The Walt Disney Company, and Rupert Murdoch, Executive Chairman, 21st Century Fox (Photo: Business Wire) The new “Fox” will include iconic branded properties Fox News Channel, Fox Business Network, Fox Broadcasting Company, Fox Sports, Fox Television Stations Group, and sports cable networks FS1, FS2, Fox Deportes and B
First Eagle Investment Management to Absorb Costs of External Research14.12.2017 14:00 | Tiedote
First Eagle Investment Management announced today that effective January 3, 2018, it will absorb the costs of all external research purchased by First Eagle investment teams. Industry practices regarding payments for external research are evolving due to the Markets in Financial Instruments Directive II (MiFID II), an EU directive requiring the unbundling of external research costs from trade execution costs. As a result, asset managers worldwide have been considering whether to pass the costs of external research to their clients or to pay them from their own resources. “While our firm is not subject to MiFID II, we believe that this part of the directive points the way forward for our industry,” said Mehdi Mahmud, President and Chief Executive Officer of First Eagle Investment Management. “To be equitable and consistent across our entire client base, we have decided to use
Cognitec Brings Unique Video Investigation Features to Face Recognition Product for Law Enforcement14.12.2017 12:38 | Tiedote
Cognitec Systems, the face recognition company, has significantly extended the feature set of its FaceVACS-DBScan product. The latest release combines the company’s renowned image database search technology with powerful video inspection tools for a multitude of investigation use cases. FaceVACS-DBScan LE enables fast import of video footage and detailed investigations of the extracted facial images. Agents can find known or unknown persons in multiple videos to quickly narrow down suspect investigations. The investigation can reveal, for example, if a suspect was seen in various locations within a set time window, always with the same group of persons, or in one location too many times during the day. With one click, the investigator can add the facial image seen in a video frame to a local database. If a person is already known, the technology can quickly compare
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme