Business Wire

Servier announces European Commission decision to convert conditional approval into standard marketing authorization in patients with aggressive non-Hodgkin B-cell lymphoma for PIXUVRI® (pixantrone)

Del

Servier today announced that the European Commission (EC) has approved the conversion of the conditional approval of PIXUVRI® (pixantrone) into a standard marketing authorization as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.

“There are limited treatment options for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma,” said Prof Pier Luigi Zinzani from the University of Bologna Institute of Hematology and Medical Oncology in Bologna, Italy. “PIXUVRI has demonstrated efficacy in late stage disease and the EC approval confirms PIXUVRI as a treatment option for these patients.”

The EC approval is based on data from the global clinical development of PIXUVRI.

The pivotal study, PIX301 was an open-label, randomized, Phase III study comparing PIXUVRI monotherapy with physician's choice of treatment in 140 patients with relapsed or refractory aggressive non-Hodgkin lymphoma, 50% of whom had been previously treated with rituximab. PIXUVRI was shown to be beneficial in these patients: 20% of patients responded completely to PIXUVRI compared with 5.7% of patients receiving other agents (p=0.021).1,2

To satisfy requirements of the conditional authorization, a further Phase III clinical study, PIX306, was completed to provide additional efficacy data to confirm the benefit of PIXUVRI in patients that had received prior treatment regimens containing rituximab. In the study PIX306, all patients were previously treated with rituximab. While the superiority of PIXUVRI with rituximab compared to gemcitabine with rituximab was not met, both progression-free survival and overall survival results in patients with ≥ 2 prior treatment lines were similar, when indirectly compared to the PIXUVRI treated population in the pivotal study PIX301.2,3

“At Servier, we work diligently to develop and deliver medicines that address critical unmet medical needs in diseases such as multiply relapsed or refractory aggressive non-Hodgkin lymphoma,” said Patrick Therasse, Head of Servier Research and Development Oncology. “PIXUVRI has been benefitting patients since its conditional approval in 2012 but today’s decision brings reassurance to patients and clinicians that this medicine remains a relevant treatment option in this indication.”

The most common side effects with PIXUVRI are neutropenia, leukopenia, lymphopenia, anemia, thrombocytopenia, nausea, vomiting, skin discolouration, alopecia, chromaturia and asthenia.1

#ENDS#

About non-Hodgkin lymphoma (NHL)

NHL is a blood cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.4 The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.5

NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.6 Around 168,000 new cases of NHL are diagnosed in the United States and Europe every year.

About PIXUVRI (pixantrone)

PIXUVRI is indicated in the European Union as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.7 PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells cannot divide and eventually die.8

PIXUVRI is mentioned in the ESMO guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.9

More detail is available in the summary of the European public assessment report (EPAR) on the EMA website at www.ema.europa.eu.

Servier commercializes PIXUVRI under a license from CTI BioPharma.

About Servier

Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a turnover of 4.2 billion euros in 2018, Servier employs 22,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generics) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.

Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are twelve molecular entities in clinical development in this area, targeting gastro-intestinal and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

Find us on Social Media:

1 European Medicines Agency. Pixuvri SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/pixuvri-epar-product-information_en.pdf [last accessed May 2019].

2 Pettengell, R. et al. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol 2012; 13: 696–706

3 Salles, G.A, et al. Results of a phase 3 randomized multicenter study comparing pixantrone + rituximab with gemcitabine + rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation. American Society Hematology annual congress 2018. P4189.

4 NHS Conditions webpage. NHL Cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed May 2019].

5 Cancer Research UK. Lymphatic System. Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer [last accessed May 2019].

6 Cancer Research UK. What is NHL cancer. Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma [last accessed May 2019].

7 Pixuvri Summary of Product Characteristics, Available at: https://www.medicines.org.uk/emc/medicine/29829 [last accessed May 2019].

8 European Medicines Agency. Summary of the European public assessment report (EPAR) for Pixuvri. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/pixuvri [last accessed May 2019].

9 Tilly H et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology (2015). Volume 26 (suppl 5); v116-v125. Available at http://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma [last accessed May 2019].

Contact information

Servier Media Relations
Sonia MARQUES: media@servier.com
Tel.: +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13

Jean-Clément VERGEAU: media@servier.com
Tel.: +33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96

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

Three Finalists Selected Following GA-ASI’s Blue Magic Belgium Event15.6.2019 11:00:00 CESTPressemelding

Three finalists have been selected from GA-ASI’s Blue Magic Belgium event with the goal of supporting GA-ASI and the development of MQ-9B SkyGuardian Remotely Piloted Aircraft (RPA) for Belgium. The three Belgian companies selected are AIRobot, ALX Systems, and Hexagon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190615005003/en/ "We were very impressed by the many talented companies and particularly by the innovative concepts presented by these three finalists," said Linden Blue, CEO, GA-ASI. (Photo: Business Wire) AIRobot, a company based at DronePort in Sint Truiden, Belgium, focuses on developing drone performance equipment for easy, precise and safe professional operations, while specializing in Artificial Intelligence (AI) for processing hyper-spectral imagery. ALX Systems is an Unmanned Aircraft System (UAS) solution provider based in Liège, Belgium and specializing in AI for processing Full Motion Video. Hexagon’s

World’s First E-Money License for Blockchains Issued to Monerium15.6.2019 08:35:00 CESTPressemelding

Monerium ehf. has received a license from the Financial Supervisory Authority of Iceland to issue e-money on blockchains through its subsidiary, Monerium EMI ehf. The full license is the world’s first e-money license for blockchains issued under EU e-money regulations. The license is passportable within the largest global economic zone, the European Economic Area, and to external jurisdictions subject to regulatory approval and destination country regulations. Designed as a digital alternative to cash, e-money is a proven framework for digital fiat currency already in use for pre-paid cards and mobile wallets. By issuing e-money on blockchains, Monerium removes the need for intermediaries and provides the ability to automate financial transactions in many sectors, including payments, trade finance, securities settlement, and ecommerce. At the same time, e-money on blockchains extends Satoshi Nakamoto’s vision of online peer-to-peer currency transactions to a regulated form of digital f

Mattel® Unveils Hot Wheels™ id, Groundbreaking New Play System Bringing Together Physical and Digital Play, Available Exclusively at Apple.com, Select Apple Stores and on the App Store14.6.2019 13:00:00 CESTPressemelding

Mattel, Inc. (NASDAQ: MAT) today announced the launch of Hot Wheels id, the evolution of the beloved brand that generations of kids have played with to ignite their challenger spirit. Through innovative vehicle play, Hot Wheels id brings together physical and digital in a Mixed Play experience with uniquely identifiable vehicles, a smart Race Portal, Smart Track, and digital hub, so you can build your personalized fleet, measure your performance, and compete like never before. Hot Wheels id is available starting June 14th exclusively at Apple.com, select Apple stores and on the App Store. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190614005084/en/ Hot Wheels Race Portal™ scans your Hot Wheels id vehicles into the app, tracks speed and counts laps via infrared sensors, and easily connects with your classic Hot Wheels track. (Photo: Business Wire) For the first time in history, kids can scan their Hot Wheels id cars digita

S BLOCK Co-host With World Blockchain Forum Singapore & World Blockchain Award Asia14.6.2019 12:45:00 CESTPressemelding

Asia's highly anticipated blockchain event World Blockchain Forum · Singapore & World Blockchain Award · Asia will be held on June 22-23, 2019 at the Marina Bay Sands in Singapore. The conference will bring together more than 4,000 global elites from government, associations, regulatory agencies, investment institutions, blockchain project parties, financial technology, and media to discuss industry trends and innovations, jointly recognizing industry pioneers and contributions to promote the industry and achieve healthy and rapid development! The World Blockchain Forum Singapore & World Blockchain Award Asia will be co-hosted by S BLOCK. As a fast-growing digital asset management platform, S BLOCK was developed for the blockchain industry. This rapidly growing platform aims to serve the digital financial ecosystem and aims to commercialize by the end of 2019. The slogan of S BLOCK is “unleash your digital asset.” The platform also provides investors access to mainstream cryptocurrenci

Janssen Reports Top-Line Phase 3 Results for TREMFYA® (guselkumab) in Adults with Active Psoriatic Arthritis14.6.2019 11:39:00 CESTPressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent with previous studies of guselkumab and current prescribing information.1 The DISCOVER programme comprises the first-ever Phase 3 studies evaluating an IL-23 p19 inhibitor for the treatment of psoriatic arthritis, and data will be presented at upcoming scientific medical meetings. Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for

Velodyne Features Advanced Lidar for Port Terminal Automation at TOC Europe14.6.2019 10:00:00 CESTPressemelding

Velodyne Lidar, Inc. (Stand A50) will demonstrate how its smart, powerful lidar solutions can advance port terminal automation at TOC Europe in Rotterdam, 18-20 June. Velodyne will highlight customer applications that show how its lidar sensors can be used in crane steering, container handling, internal terminal vehicles (ITV), automated guided vehicles (AGV), forklifts, and terminal security/yard monitoring systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190614005040/en/ DGWorld solutions demonstrate how Velodyne’s intelligent lidar sensors are helping port and terminal operators deliver consistent service quality and achieve increased safety. (Photo: Business Wire) DGWorld (Stand B21A), a Dubai-based Velodyne integrator, will showcase autonomous taxis, ITVs, AGVs, and terminal operation vehicles that use Velodyne lidar sensors to run autonomously. These vehicles use advanced artificial intelligence (AI), automation