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
New Auction Record Set as Falcon Sells for AED 1.5 Million at ADIHEX 202629.8.2026 23:54:00 CEST | Press release
Qarmousha Pure Ultra White falcon sells for AED 1.5 million at the Abu Dhabi International Hunting and Equestrian Exhibition 2026 (ADIHEX) falcon auction Under the patronage of His Highness Sheikh Hamdan bin Zayed Al Nahyan, Ruler’s Representative in Al Dhafra Region and Chairman of the Emirates Falconers’ Club, the fifth auction held as part of the 23rd edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) 2026 attracted remarkable turnout, culminating in the sale of a Qarmousha Pure Ultra White falcon for AED 1.5 million (USD 408,000). The sale marks the highest price achieved at any auction during this year’s edition of the exhibition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260829032621/en/ Qarmousha Pure Ultra White (Photo: AETOSWire) This forms part of the largest auction programme in the exhibition’s history, held under the theme “A Legacy of Pride,” organised by ADNEC Group, a Modon
Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera29.8.2026 00:40:00 CEST | Press release
MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve FatigueApproval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/ MIMRYLO Logo MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the tot
Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 16:00:00 CEST | Press release
Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me
BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 15:34:00 CEST | Press release
Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are pro
Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations28.8.2026 11:00:00 CEST | Press release
Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely
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