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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 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.4Jevtana® (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).5Today’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.”

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.8,9Jevtanawas 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 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.1,2,5It 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.

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] 

Date of preparation: December 2016 - Job bag number: SAGB.CAB.16.12.1127

Updated: December 12, 2016

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