PIXUVRI® (pixantrone) Receives Positive CHMP Opinion to Convert Conditional Approval into Standard Marketing Authorization in Patients with Aggressive non-Hodgkin B-cell Lymphoma
Servier today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for PIXUVRI® (pixantrone) to convert its conditional approval 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. The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.
In 2012, in recognition of the lack of standard of care and the poor prognosis for patients with aggressive non-Hodgkin B-cell lymphoma, the EMA gave a conditional marketing authorization for PIXUVRI® as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.1 Conditional marketing authorizations are granted in the EU to speed access to products that address unmet medical needs and where availability would result in a significant public health benefit.
"Patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma have limited treatment options,” said Prof Pier Luigi Zinzani from the University of Bologna Institute of Hematology and Medical Oncology in Bologna, Italy. “In this patient population, PIXUVRI® offers a treatment option in later lines.”
The positive opinion from the CHMP 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).2,3
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 with rituximab. In the study PIX306, all patients were previously treated with rituximab, and the treatment was possible as a second line. While the superiority of PIXUVRI® over comparator was not met, both PFS and OS results in patients with ≥ 2 prior treatment lines are comparable, when indirectly compared to the PIXUVRI® treated population in the pivotal study PIX301.3,4
The most common side effects with PIXUVRI® are neutropenia, leukopenia, lymphopenia, anemia, thrombocytopenia, nausea, vomiting, skin discolouration, alopecia, chromaturia and asthenia.2
“Aggressive non-Hodgkin B-cell lymphoma is a devastating disease for which treatment options are limited. Servier is committed to providing PIXUVRI® to these patients so we are very pleased with today’s announcement,” said Patrick Therasse, Head of Servier Research and Development Oncology Department. “At Servier, oncology is one of our priorities. We will continue to work hard to get new therapeutic options to people affected by cancer.”
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.5 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.6
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.7 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.8 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.1
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.
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 eleven 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. Summary of the European public
assessment report (EPAR) for Pixuvri. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/pixuvri
[last accessed March 2019].
2 European Medicines Agency. Pixuvri SmPC. Available at: https://www.ema.europa.eu/en/documents/product-information/pixuvri-epar-product-information_en.pdf [last accessed March 2019].
3 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
4 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.
5 NHS Conditions webpage. NHL Cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed March 2019].
6 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 March 2019].
7 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 March 2019].
8 Pixuvri Summary of Product Characteristics, Available at: https://www.medicines.org.uk/emc/medicine/29829 [last accessed March 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 March 2019].
Sonia MARQUES: email@example.com – Tel.: +33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13
Jean-Clément VERGEAU: firstname.lastname@example.org – Tel.: +33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Empirix Announces Support for Traffic Analysis Across 5G Non-Stand-Alone Architectures21.8.2019 12:16:00 EEST | Press release
Empirix Inc., a premier global provider of voice and data service assurance solutions, today announced the ability to monitor 5G user and control plane traffic in accordance with 3GPP Release 15 Non-Stand-Alone (NSA) Architecture options 3/3a/3x. Entrusted to monitor and troubleshoot some of the world’s largest networks, Empirix’s service assurance platform, Diagnostix, formerly known as E-XMS, is capable of monitoring both hybrid and pure cloud-native 5G networks. This puts Empirix in a unique position to support communication service providers who have identified a migration path for their networks to 5G. 3GPP option 3x is emerging as the preferred choice for service providers who want to leverage previous-generation LTE networks. Largely based on the introduction of 5G Radio Access, this standard allows mobile providers to enhance both Quality of Service (QoS) and Quality of Experience (QoE) for their customers by integrating LTE core networks with non-standalone 5G radio systems. W
Innodisk Introduces First Hybrid Edge and Cloud SSD Solution with Microsoft Azure Sphere™21.8.2019 11:00:00 EEST | Press release
Innodisk, the world’s leading industrial storage provider, unveiled the InnoAGE™ SSD, the world’s first with native Microsoft Azure Sphere™ integration. Formally introduced at the Innodisk-hosted AIoT Summit during Flash Memory Summit 2019 (FMS 2019), the InnoAGE SSD, with Microsoft Azure Sphere inside, enables multifunctional management for smart data analysis and updates, data security, and remote control through the cloud. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190821005192/en/ InnoAGE SSD is the first Azure Sphere inside solution with a patent. Enable in-band management and out of band management (Photo: Business Wire) “Our tight-knit collaboration with Microsoft has resulted in real innovation aimed at solving the very real challenges businesses face today,” said Innodisk President Randy Chien. “The InnoAGE™ SSD is the first and only hybrid solution designed solely with the AIoT architecture in mind, utilizing d
Topcon to Attend EURETINA 2019 Meeting21.8.2019 07:00:00 EEST | Press release
Topcon Europe Medical, a leading provider of medical devices and software solutions for the European eye care community, is excited to announce its participation in EURETINA 2019, the European Society of Retinal Specialists’ annual congress, which has become internationally renowned as the largest retina meeting worldwide. On 5-8 September, thousands of vitreoretinal and macula specialists will gather at the Palais des Congrès de Paris in France to share information on the latest trends and advances in vitreoretinal surgery and the diagnosis and treatment of retinal diseases including macular degeneration and diabetic retinopathy. Topcon will be located in the Exhibit Hall, Level 2 at Booth #219 and will showcase its latest innovative technology solutions for today’s retina specialists including the Triton Swept Source OCT, the newly released Maestro Fully Automated OCT with Angiography, Artificial Intelligence systems, the all new Topcon Signal Hand-held Camera, and the PASCAL Laser S
IFF to Present at Barclays Global Consumer Staples Conference September 520.8.2019 23:15:00 EEST | Press release
Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition & ingredients today announced that the Company’s management will speak at the Barclays Global Consumer Staples Conference in Boston, Massachusetts, on Thursday, Sept 5, 2019 at 2:15 PM ET. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/ho
Novalis LifeSciences Launches its First Life Science Investment Fund with $85 Million20.8.2019 19:29:00 EEST | Press release
August 20th, 2019, Novalis LifeSciences, an investment and advisory firm for the Life Science industry, announced today that it has raised $85M in capital for its first fund - Novalis LifeSciences Investments I, L.P. Novalis LifeSciences is focused on highly innovative Life Science companies. On the occasion of closing the first fund, Marijn E. Dekkers, founder and chairman, said: “This first fund is a growth-oriented fund that will invest in 8-12 companies that are commercializing breakthrough technologies in various segments of the Life Science industry. This includes drug discovery, life science tools, genomics, synthetic biology, diagnostics, and agricultural biotechnology – all areas with huge unmet needs and exciting opportunities for investors”. About Novalis LifeSciences Novalis Lifesciences LLC, is a globally acting venture capital firm focused on breakthrough technologies in Life Science. Founded and managed by Dr. Marijn E. Dekkers, current chairman of Unilever and former ch
Bermuda Tech Week 2019 to Celebrate Innovation and Explore Opportunities for Growth20.8.2019 17:27:00 EEST | Press release
Registration is under way and filling fast for Bermuda Tech Week 2019 which will take place at the Hamilton Princess & Beach Club from October 14-18, 2019. The programme of insightful and engaging events will explore future opportunities and challenges presented by emerging technologies such as artificial intelligence, blockchain, digital assets, insurtech and virtual reality. It will showcase Bermuda’s ongoing success in creating a welcoming, stable and well-regulated environment where technology and start-up companies can thrive. “Bermuda has a long history of innovation so we understand and recognise the power of technology to positively impact both the economy and society,” said Bermuda Premier David Burt. “Over the past two years, we have built on our strength as a global leader in regulating the risks associated with the global insurance industry to develop a clear regulatory framework around managing the risks associated with Fintech. Our progressive approach has drawn accolades
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