SERVIER
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].
View source version on businesswire.com: https://www.businesswire.com/news/home/20190613005025/en/
Contact:
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
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Nippon Electric Glass to Start World’s First Mass Production of Low-Carbon Pharmaceutical Glass Tubing Using an All-Electric Furnace16.12.2025 03:00:00 CET | Press release
Nippon Electric Glass Co., Ltd. (NEG)(TOKYO:5214), a global leader in specialty glass headquartered in Otsu, Japan, announced it will begin the world’s first mass production of pharmaceutical-grade glass tubing using an all-electric melting furnace. Commercial production is scheduled to start in December 2025 at its subsidiary in Selangor, Malaysia. This breakthrough introduces a new manufacturing model for pharmaceutical packaging. By combining NEG’s proprietary all-electric melting technology with renewable energy, CO2 emissions from glass tubing production can be reduced by up to 90%*1 compared with conventional fossil-fuel combustion furnaces. This positions NEG as a major supplier capable of delivering both high-performance borosilicate glass and a significantly lower carbon footprint, directly addressing global sustainability demands from pharmaceutical companies and regulators. NEG is a leading global supplier of arsenic-free, environmentally friendly borosilicate glass tubing f
Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform16.12.2025 02:00:00 CET | Press release
Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025. Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery. ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platfo
Civil Air Patrol Expands Fleet With 15 New Cessna Aircraft to Support Lifesaving and Community Missions15.12.2025 17:00:00 CET | Press release
Latest deliveries bring CAP’s Cessna fleet to more than 500 aircraft nationwide Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, announced today that Civil Air Patrol (CAP), the world’s largest operator of Cessna aircraft, is strengthening its national mission capabilities with an order for 15 additional piston-engine aircraft, including seven Cessna Skyhawk 172 and eight Cessna Skylane 182 models scheduled for delivery throughout 2026. The order follows recent deliveries of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft, expanding CAP’s fleet to more than 500 Cessna aircraft nationwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215613573/en/ Delivery of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft joins CAP’s fleet of more than 500 Cessna aircraft nationwide. Cessna aircraft are designed and produced by Textron Aviation. “Civil Air Patrol’s miss
Winston & Strawn and Taylor Wessing UK to Combine, Creating a Premier Transatlantic Law Firm15.12.2025 16:52:00 CET | Press release
Winston Taylor to build on shared vision and culture in establishing a transatlantic powerhouse for major litigation, critical transactions, strategic IP, and private wealth Winston & Strawn and Taylor Wessing’s UK-led business announced today their intention to combine, creating a premier transatlantic law firm that would operate under a new shared name, Winston Taylor. The combination responds to increasing client demand for seamlessly integrated US–UK–EU counsel for the businesses, people, and markets driving capital and innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215914957/en/ The combination once final will unite two international firms with more than 400 years of combined history, complementary strengths, and a common vision to meet clients’ evolving global needs. The combined firm will include more than 1,400 lawyers, establishing one of the largest transatlantic firms whose footprint is primarily in
Despite Barriers, Financial Institutions are Clear About AI's Greatest Impact15.12.2025 16:32:00 CET | Press release
HTEC Finds AI is Everywhere in FSI, but Scaling Across the Enterprise Remains the Industry's Biggest Hurdle HTEC, a global AI-first provider of software and hardware design and engineering services, today released The State of AI in Financial Services & Insurance 2025, a first industry subset of its global research report in AI. This publication offers one of the clearest views to date into how financial institutions are adopting and scaling artificial intelligence. This industry-focused report analyzes insights from 250 C-suite leaders within financial services and insurance, drawn from HTEC’s broader global study of 1,529 C-suite executives—including CIOs, CTOs, CDOs, CPOs, CFOs, COOs, CEOs and CSOs—across Saudi Arabia, the UAE, the United Kingdom, the United States, Germany and Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215790717/en/ Executive Summary: The State of AI in Financial Services and Insurance 2025
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom