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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)

Pixantrone has been available to patients since 2012 following a
conditional approval in Europe

PARIS–(BUSINESS WIRE)–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

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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].

Contacts

Servier Media Relations
Sonia MARQUES: [email protected]
Tel.:
+33 (0)1 55 72 40 21 / + 33 (0)7 84 28 76 13

Jean-Clément VERGEAU: [email protected]
Tel.:
+33 (0)1 55 72 46 16 / +33 (0)6 79 56 75 96

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