Second-line treatment for adults with
mycosis fungoides or Sézary syndrome included in the Ministry of
Health’s Drug Programme effective as of 1st July 2024.
Kyowa Kirin International (KKI), a wholly owned subsidiary of
Kyowa Kirin Co. Ltd., and Swixx BioPharma AG today announced that
the Polish Ministry of Health has approved the reimbursement of
POTELIGEO® (mogamulizumab) in second-line monotherapy for adult
patients with Stage IB and above mycosis fungoides (MF), and Sézary
syndrome (SS).
MF and SS are two subtypes of cutaneous T-cell lymphoma (CTCL),
a rare form of non-Hodgkin’s lymphoma that presents and persists in
the skin and can have debilitating physical, emotional and social
challenges.1 MF—the most common CTCL subtype—accounts for
approximately 60% of all CTCLs.2
With an average time to diagnosis of 3-4 years, MF is typically
characterised by skin symptoms including patches or plaques, skin
redness and tumours.3,4 SS is much rarer, accounting for around 5%
of CTCLs,5 and is more aggressive, causing severe itching,
erythroderma, intense scaling of the skin and frequent hair
loss.6
Jeremy Morgan, President of Kyowa Kirin International,
commented: “I am delighted that the Ministry of Health has agreed
to reimburse POTELIGEO for MF and SS patients in Poland. Our
purpose at Kyowa Kirin is to make people smile, and I am proud to
see us living this purpose and achieving such an important
milestone for the CTCL community. With a commitment to delivering
life changing value for people impacted by under-diagnosed and
under-served diseases, approval in Poland now means mogamulizumab
is reimbursed in almost 30 countries across the EMEA region, and is
a critical step in helping to meet the needs of people living with
CTCL.”
Kyowa Kirin International and Swixx BioPharma AG signed a
Promotion and Distribution Agreement in October 2022. Under the
terms of the agreement, Swixx exclusively markets, promotes and
distributes mogamulizumab in Poland.
Michał Opuchlik, General Manager of Swixx BioPharma Poland,
commented: “The positive reimbursement decision of the Polish
Ministry of Health is surely an important achievement for patients
in Poland suffering from CTCL. We are very proud that, thanks to
the great cooperation between Swixx BioPharma, Kyowa Kirin and all
our stakeholders in Poland, we were able to ensure that patients
now have access to this medicine, that received the FDA's
breakthrough therapy designation several years ago. At Swixx
BioPharma we are proud of our mission to bring the innovative
therapies of our partners to patients in need and this milestone
once again positions Swixx BioPharma Poland among the leading
companies securing access to innovative treatments in our
country.”
About Poteligeo (mogamulizumab)
Mogamulizumab is a first-in-class humanised monoclonal antibody
directed against CC-chemokine receptor 4 (CCR4), a protein
consistently expressed on cancerous cells seen in both MF and
SS,7-9 once mogamulizumab binds to CCR4, it increases attraction of
immune cells from the immune system to destroy the cancerous
cells.10
About MF and SS
MF and SS are two subtypes of CTCL, which is itself a rare form
of non-Hodgkin’s lymphoma that presents and persists in the skin.1
CTCL is treatable, but is not generally considered to be curable,
and there has been a clear unmet need for novel treatment options.
As well as the obvious impact of symptoms upon patients, there can
be significant erosions to quality of life for those caring for an
individual living with CTCL.11
MF and SS are characterised by localisation of cancerous white
blood cells called T lymphocytes (T cells), to the skin.12 These
cancerous T cells consistently express a protein called CCR4, which
enables them to move from the blood to the skin.7-9 When these
cancerous T cells move to the skin, this results in the visible
early skin symptoms of red patches or plaques which can resemble
psoriasis or eczema in the early stages of the disease.13 Later,
for some patients, skin involvement may evolve to include tumours
or reddening of the majority of the skin’s surface
(erythroderma).
MF—the most common CTCL subtype—accounts for approximately 60%
of all CTCLs2 and is typically indolent, characterised by skin
symptoms including patches or plaques, skin redness and tumours.3,4
SS is much rarer, accounting for around 5% of CTCLs,5 and is more
aggressive,6 with high levels of blood involvement.5 It can cause
severe itching, erythroderma, intense scaling of the skin and
frequent hair loss.6 CTCL can take, on average, between 2 and 7
years for individuals to receive a confirmed diagnosis.13
About Kyowa Kirin
Kyowa Kirin aims to discover novel medicines with life-changing
value. As a Japan-based Global Specialty Pharmaceutical Company, we
have invested in drug discovery and biotechnology innovation for
more than 70 years and are currently working to engineer the next
generation of antibodies and cell and gene therapies with the
potential to help patients affected by severe and rare diseases. A
shared commitment to our values, to sustainable growth, and to
making people smile unites us across our four regions – Japan, Asia
Pacific, North America, and EMEA/International.
You can learn more about the business of Kyowa Kirin at:
https://www.kyowakirin.com
About Swixx BioPharma AG
Swixx BioPharma is one of the fastest-growing, largest,
intercontinental commercial platforms for the biopharmaceutical
industry. Swixx operates subsidiaries across Central and Eastern
Europe, Greece, Russia, several Eurasian countries, the Middle
East, and via Biopas, a Swixx BioPharma company, in almost 20 Latin
American countries. Swixx BioPharma Group has over 1,600 employees
and sales likely to exceed a billion Euros in 2024. The company has
gathered outstanding rare disease, oncology-hematology, specialty,
vaccines and self-medication talent under one roof.
For more information about Swixx BioPharma, please visit:
www.swixxbiopharma.com
References
1Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus
vorinostat in previously treated cutaneous T-cell lymphoma
(MAVORIC): an international, open-label, randomised, controlled
phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. 2Willemze R, et
al. The 2018 update of the WHO-EORTC classification for primary
cutaneous lymphomas. Blood. 2019;133(16):1703-1714. 3Scarisbrick,
J, et al. The PROCLIPI international registry of early-stage
mycosis fungoides identifies substantial diagnostic delay in most
patients. Br J Dermatol. 2019;181(20):350–357. 4Demierre M-F, et
al. Significant impact of cutaneous T-cell lymphoma on patients’
quality of life. Cancer. 2006;107(10):2504-2511. 5Trautinger F, et
al. European Organisation for Research and Treatment of Cancer
consensus recommendations for the treatment of
mycosisfungoides/Sézary syndrome - Update 2017. European Journal of
Cancer. 2017;77:57–74. 6Lymphoma Coalition. Cutaneous lymphoma – a
patient’s guide. Available at:
https://lymphomacoalition.org/wpcontent/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf.
Last accessed: July 2024 7Ferenczi K, et al. Increased CCR4
expression in cutaneous T cell lymphoma. J Invest Dermatol.
2002;119:1405–10. 8Yoshie O, et al. Frequent Expression of CCR4 in
Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type
1-transformed T cells. Blood. 2002;99(5):1505–11. 9Ishida T, et al.
Clinical Significance of CCR4 Expression in Adult T-cell
Leukemia/Lymphoma: Its Close Association With Skin Involvement and
Unfavorable Outcome. Clin Cancer Res. 2003;9:3625–34. 10Duvic M, et
al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma:
recent advances and clinical potential. Ther Adv Hematol.
2016;7(3):171–174. 11Williams et al (2020) – Health state utilities
associated with caring for an individual with CTCL. Journal of
Medical Economics. 2020; 23(10):1142-1150. 12Scarisbrick JJ, Prince
M, Vermeer MH, et al. Cutaneous Lymphoma International Consortium
Study of Outcome in Advanced Stages of Mycosis Fungoides and Sézary
Syndrome: Effect of Specific Prognostic Markers on Survival and
Development of a Prognostic Model. J Clin Oncol.
2015;33(32):3766-3773. 13Cutaneous Lymphoma Foundation, Lymphoma
Action and Lymphoma Coalition Europe. Cutaneous lymphoma – a
patient’s guide. 2019. Available from:
https://lymphomacoalition.org/wpcontent/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf.
Last accessed: July 2024.
KKI/INT/MOG/1166 Date of preparation: July 2024
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version on businesswire.com: https://www.businesswire.com/news/home/20240731235221/en/
Stacey Minton Stacey.Minton@kyowakirin.com