OXFORD, England, December 12, 2016 /PRNewswire/ --
Jevtana® (cabazitaxel)
for Men With Metastatic Hormone-refractory Prostate Cancer Accepted
for Routine use in NHS Scotland
Sanofi Genzyme, the specialty care global business unit of
Sanofi, today announced that the Scottish Medicines Consortium
(SMC) has accepted Jevtana® (cabazitaxel) for routine
use in NHS Scotland for the treatment of metastatic
hormone-refractory prostate cancer (mHRPC).[1] With this
decision, Scotland is now aligned
with health authorities in England, Wales and Northern
Ireland, thereby reducing potential disparities in care
across the UK for this vulnerable group of patients.[2]
"This is positive news for men in
Scotland who now have
the same access as other men in the UK to
treatment that increases their chance
to live longer," said Roger Wotton, Chairman at prostate cancer
patients' charity TACKLE. "Any extension of time a
man with prostate cancer is able to get back to be with family and
friends is highly important. The availability
of Jevtana means men in Scotland now have an alternative
effective treatment option. Likewise, physicians now
have another medicine in their arsenal to treat
patients."
In Scotland, nearly 1 in 2 men
will be affected by some form of prostate disease at some stage of
their lives and approximately 1 in 11 men are likely to develop
prostate cancer, the most common cancer in men in Scotland.[3] In time, most prostate
cancers become resistant to hormone therapy and continue to grow
despite treatment.[4] Jevtana® (cabazitaxel)
is the only remaining chemotherapy option available on the NHS for
advanced prostate cancer that is not responsive to hormone
therapies, following initial chemotherapy
(docetaxel).[5] Today's SMC announcement comes after
Sanofi Genzyme provided an updated submission to the SMC who
rejected its initial application in June.[6]
"We were dedicated to working with the
SMC to ensure that the outcome of this review
resulted in a positive outcome for patients,"
said Dr. Jasmin Hussein, Oncology
& Immunology Franchise Director UK & Ireland at Sanofi Genzyme.
"Through ongoing collaboration our treatment
can now be accessed by all doctors who
treat patients with metastatic hormone-refractory
prostate cancer in the country. The approval
of Jevtana by the SMC is important, as
it represents a new treatment choice where limited options have
existed."
- Ends -
About Jevtana® (cabazitaxel)
Jevtana® (cabazitaxel) is a taxane (plant-based)
chemotherapy that may be active in cancer cells which are resistant
to
docetaxel.[7],[8],[9]
Jevtana® works by inhibiting cell division, causing
cancer cell
death.[8],[9]Jevtana
was shown to extend survival in patients with advanced prostate
cancer over an active comparator in the pivotal TROPIC
study[5]. Jevtana® is
the only chemotherapy option recommended by UK Health Technologies
Assessment agencies (HTA) to treat advanced prostate cancer which
is not responsive to hormonal therapies following initial
chemotherapy with
docetaxel.[1],[2],[5]
It is licensed in the UK and the rest of Europe for use in men with hormone refractory
metastatic prostate cancer.
Patients treated with Jevtana® (cabazitaxel) can
experience side effects, which most commonly include anaemia,
infections/sepsis, low blood counts and diarrhoea. For further
details please refer to the full Summary of Product Characteristics
at: http://www.medicines.org.uk/emc/medicine/24431
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and
distributes therapeutic solutions focused on patients' needs.
Sanofi is organized into five global business units: Diabetes and
Cardiovascular, General Medicines and Emerging Markets, Sanofi
Genzyme, Sanofi Pasteur and Merial.
Sanofi Genzyme focuses on developing specialty treatments for
debilitating diseases that are often difficult to diagnose and
treat, providing hope to patients and their families.
Genzyme® is a registered trademark of Genzyme
Corporation. Sanofi® is a registered trademark of
Sanofi. All rights reserved.
References
[1] Scottish Medicines Consortium. SMC
Advice Directory.
https://www.scottishmedicines.org.uk/SMC_Advice/Advice_Directory/SMC_Advice_Directory
[Accessed December 2016]
[2] National Institute for
Health and Care Excellence (NICE). Technology Appraisal Guidance
(TAG) Cabazitaxel for hormone-relapsed metastatic prostate cancer
treated with docetaxel. https://www.nice.org.uk/guidance/TA391
[Accessed December 2016]
[3] Prostate Scotland. Disease of the prostate.
http://www.prostatescotland.org.uk/diseases-of-the-prostate/prostate-cancer.html
[Accessed December 2016]
[4] National Cancer Institute.
2014. Hormone Therapy for Prostate Cancer.
http://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet
[Accessed December 2016]
[5] De Bono JS, Oudard S,
Ozguroglu M et al., Prednisone plus cabazitaxel or mitoxantrone for
metastatic castration-resistant prostate cancer progressing after
docetaxel treatment: a randomized open-label trial. Lancet
2010;376 :1147-54
[6] Scottish Medicines
Consortium. SMC Advice. Briefing note: cabazitaxel (Jevtana)
https://www.scottishmedicines.org.uk/SMC_Advice/Advice/735_11_cabazitaxel_Jevtana/Briefing_Note_cabazitaxel_Jevtana
[Accessed December 2016]
[7] Attard G et al. Update on
tubulin-binding agents. Pathol Biol (Paris) 2006;54 :72-84
[8] Pivot X et al. A
multicenter phase II study of XPR6258 administered as a 1-h i.v.
infusion every 3 weeks in taxane-resistant metastatic breast cancer
patients. Ann Oncol 2008;19:1547-1552
[9] Jevtana Summary of Product Characteristics.
http://www.medicines.org.uk/emc/medicine/24431 . [Accessed
December 2016]
SOURCE Sanofi