Download Scottish Medicines Consortium approves Sanofi prostate cancer drug

PRESS RELEASE
Scottish Medicines Consortium approves Sanofi
prostate cancer drug
Jevtana® (cabazitaxel) for men with metastatic hormone-refractory prostate cancer
accepted for restricted use within NHS Scotland
Oxford, UK – 12 December, 2016 - Sanofi Genzyme, the specialty care global business unit of
Sanofi, today announced that the Scottish Medicines Consortium (SMC) has accepted Jevtana®
(cabazitaxel) for restricted use within NHS Scotland for the treatment of metastatic hormonerefractory 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.”
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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.8,9Jevtana was shown to extend survival in patients with advanced prostate cancer over an
active comparator in the pivotal TROPIC study5. Jevtana® is the only chemotherapy option
SAGB.CAB.16.12.1127
Date of Preparation: December 2016
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.
The newly published advice from the SMC on the use of Jevtana® (cabazitaxel) in combination with
prednisone or prednisolone within the NHS Scotland for people with mHRPC previously treated with
a docetaxel-containing regimen, states that it can be used only if:
• the person has received at least 225 mg/m2 (three cycles) of docetaxel and
• the person has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
1.
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: 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.
Contacts:
Media Relations
Stefanie Holman
Sanofi Genzyme UK & Ireland
Tel.: 01865 405 200 or 07740 935 273
[email protected]
References
1
Scottish Medicines Consortium. SMC Advice. cabazitaxel (Jevtana).
https://www.scottishmedicines.org.uk/SMC_Advice/Advice/735_11_cabazitaxel_Jevtana/cabazitaxel_Jevtana_2nd_Resub [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-hormonetherapy-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. www.medicines.org.uk/emc/medicine/24431. [Accessed December 2016] SAGB.CAB.16.12.1127
Date of Preparation: December 2016