SERVIER
13.6.2019 09:02:04 CEST | Business Wire | Press release
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
euNetworks launches new quantum-safe private connectivity service powered by Adtran’s encrypted optical transport technology27.5.2026 10:00:00 CEST | Press release
News summary: Developed by euNetworks to deliver the highest levels of protection for sensitive data moving between European data centers Built on Adtran’s solution, euNetworks’ new Quantum Shield service enables quantum-safe encryption across private high-capacity connectivity, with continuous optical and fiber plant monitoring The new offering supports regulated industries with strong assurance against current and emerging cybersecurity threats Adtran and euNetworks today announced their collaboration on the launch of a new quantum-safe private connectivity service, Quantum Shield. euNetworks has developed Quantum Shield using Adtran’s optical transport technology to augment its broader architecture, which is designed to deliver secure, scalable data center connectivity across euNetworks’ pan-European network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526610601/en/ Adtran’s encrypted optical transport technology is
National Bank of Greece in Cyprus Goes Live With Smartstream’s Air to Consolidate Reconciliations27.5.2026 09:55:00 CEST | Press release
Key Facts National Bank of Greece in Cyprus has consolidated four previously separate reconciliations systems – Instant, Cash, SEPA, and Nostro reconciliations – into a single platform using Smartstream’s Air Cash modules. Smartstream Air’s AI-enabled capabilities significantly reduce daily manual effort, eliminate the need to work with multiple data formats, and proactively identify data quality issues from both internal sources and bank statements. Successfully deployed in three months with no existing technology to replace; Smartstream developed a custom automated encrypted file transfer solution to meet the bank’s strict data security requirements. Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces that the National Bank of Greece (NBG) in Cyprus has successfully gone live with Air, the company’s AI-enabled reconciliation solution. The go-live marks a significant step forward in the bank’s operational efficien
Duco Launches the First Agentic Operations Platform for Financial Services27.5.2026 09:20:00 CEST | Press release
Duco, today launched the first agentic Operations platform for financial services. Built on the engine that already processes 20 billion transactions every month for more than 200 clients, including seven of the top 20 banks and ten of the top 20 asset managers, the platform brings together everything firms need to run post-trade Operations alongside autonomous agents, safely and at scale. The launch establishes a breakthrough the industry has been waiting for. A tool surface, purpose-built for agents. Duco has unbundled its platform into a new alternative agent layer that reconfigures its platform into hundreds of discrete capabilities servicing post trade. Model Context Protocol (MCP) gives capabilities covering reconciliation, data preparation, data access, audit trails, exception management, document creation and more. For the first time, agents have a verified, deterministic toolset built specifically for post-trade. Agents do not replace matching, rules or audit; they use them. P
Brenus Pharma Announces FDA Acceptance of IND Application for STC-1010 (BreAK-CRC001) in MSS Metastatic Colorectal Cancer (mCRC)27.5.2026 08:49:00 CEST | Press release
STC-1010 is a first-in-class allogeneic in vivo immunotherapy for which the FDA has authorized clinical evaluation in the U.S. under the BreAK-CRC001 study. This strategic milestone enables the company to execute a global clinical strategy following European regulatory approvals (ANSM, AFMPS), first patients dosed with preliminary results and good tolerability observed in early Phase Ia. First data are expected to be presented during ESMO annual congress 2026. Brenus Pharma, a clinical stage biotechnology company developing novel in vivo immunotherapies for solid tumors, announced that the U.S. Food and Drug Administration (FDA) has accept the company's Investigational New Drug (IND) application for its first drug candidate, STC-1010, in microsatellite stable (MSS) metastatic colorectal cancer (mCRC). STC-1010 is designed to address a critical unmet need worldwide. Approximately 95% of mCRC patients have MSS tumors, which demonstrate minimal response to standard immunotherapies. The FD
Tide Crosses 2 Million Members Worldwide - Big Step Forward in Mission to Support and Grow Small Businesses27.5.2026 08:00:00 CEST | Press release
Continuing to grow in the UK and internationally, with India seeing especially strong member growth in the last 12 months In the UK, Tide has 15% market share and has helped small businesses access over £1.75bn in credit Rapid roll out of products; from admin, accounting and tax tools; subscription options; payment solutions; government registrations; bill payments and credit Tide, the UK’s leading business management platform, today announces it has crossed 2 million members globally, with India in particular seeing strong growth. More than 1.1 million small businesses joined Tide in India since the company launched there in December 2022. This makes India Tide’s fastest-growing market by member acquisition. The UK is Tide’s home market, with 900,000 SMEs, 15% market share, and the majority of the company’s revenue. Tide’s steadily expanding its presence in Europe, with Germany and France, where the platform is gaining strong traction, thanks to millions of small businesses turning to
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