Pixantrone has been available to patients since 2012 following a
conditional approval from the European Medicines Agency
PARIS–(BUSINESS WIRE)–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.”
#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.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.
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 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
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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].
Contacts
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