Genzyme in the UK

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Patients in Scotland denied prostate cancer drug

Date: 13 June, 2016

The SMC has ruled against approving Jevtana® (cabazitaxel) for advanced prostate cancer, despite recent NICE approval

Oxford, UK. – Sanofi Genzyme, the specialty care global business unit of Sanofi, is disappointed with the decision by the Scottish Medicines Consortium (SMC), recommending against the use of Jevtana® (cabazitaxel) on NHS Scotland for the treatment of metastatic hormone-relapsed prostate cancer (mHRPC) and thus denying Scottish patients access to a drug that according to the National Institute for Health and Care Excellence (NICE) is a clinically-effective and cost-effective treatment that prolongs life and is valued by patients.1

 Jevtana® (cabazitaxel) has been shown to extend survival in patients with advanced prostate cancer2 and the SMC decision, which will limit the treatment choice in Scotland, comes only a month after NICE gave Jevtana® the green light.1

“Despite recent advances in the treatment of advanced prostate cancer, clinical trials conducted in Glasgow and elsewhere have demonstrated that cabazitaxel is a life-prolonging treatment for some patients with advanced prostate cancer,” commented Rob Jones, Professor of Clinical Cancer Research at the Institute of Cancer Sciences, University of Glasgow. “I hope that Sanofi Genzyme and the health services can continue to work together to find a way to make this drug available to patients who need it in Scotland in the near future.”

In Scotland, prostate cancer is the most common cancer in men, affecting approximately 1 in 11 men at some point in their lives.3 In time, most prostate cancers become resistant to hormone therapy and continue to grow despite treatment.  Jevtana® (cabazitaxel) is the only remaining NICE approved chemotherapy option for advanced prostate cancer, which is not responsive to hormone therapies following initial chemotherapy (docetaxel).2

We are very disappointed with the recommendation from the SMC, but are in active dialogue to explore our options,” said Dr. Jasmin Hussein, Oncology & Immunology Franchise Director UK & Ireland at Sanofi Genzyme. “We have worked closely with NICE to find solutions that met their needs and are keen to re-engage in the consultative process with the SMC to potentially overcome the barriers and ensure that patients in Scotland are not disadvantaged and have access to a drug that could extend their survival and give them more time with friends and family.”

–  Ends –

About Jevtana® (cabazitaxel)

Jevtana® (cabazitaxel) is a taxane (plant-based) chemotherapy that may be active in cancer cells which are resistant to docetaxel.5,6 Jevtana® works by inhibiting cell division, causing cancer cell death.6 Jevtana® is the only remaining NICE approved chemotherapy option for advanced prostate cancer which is not responsive to hormonal therapies following initial chemotherapy with docetaxel.2,4,7,8 It is licensed in the UK and the rest of Europe for use in men with advanced prostate cancer and was available on the CDF from 2012 until its recent de-listing in March 2015.

TA391, which is the published guidance from NICE on the use of Jevtana® (cabazitaxel) in the NHS in England for people with mHRPC whose disease has progressed during or after docetaxel chemotherapy, states that it can be used only if:1
• the person has an eastern cooperative oncology group (ECOG) performance of 0 or 1*
• the person has had 225 mg/m2 or more of docetaxel
• treatment with Jevtana® is stopped when the disease progresses or after a maximum of 10 cycles (whichever happens first)
• NHS trusts purchase Jevtana®  in pre-prepared intravenous infusion bags, not in vials, and
• Sanofi provides Jevtana® with the discount agreed in the Patient Access Scheme (PAS).

Patients treated with Jevtana® (cabazitaxel) can experience side effects. Further information is available here: www.medicines.org.uk/emc/medicine/24431

*When using ECOG performance status, healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect ECOG performance status and make any adjustments they consider appropriate.

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
stefanie.holman@sanofi.com

References

1. 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 June 2016]
2. 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
3. Prostate Scotland. Disease of the prostate. http://www.prostatescotland.org.uk/diseases-of-the-prostate/prostate-cancer.html [Accessed June 2016]
4. National Cancer Institute. 2014. Hormone Therapy for Prostate Cancer. http://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet [Accessed May 2016]
5. Attard G et al. Update on tubulin-binding agents. Pathol Biol (Paris) 2006;54:72-84
6. 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
7. Antonarakis ES, et al., AR-V7 and Resistance to Enzalutamide and Abiraterone in Prostate Cancer, N Engl J Med 2014; 371:1028-1038
8. Efstathiou E, et al., Effects of Abiraterone Acetate on Androgen Signaling in Castrate-Resistant Prostate Cancer in Bone, J. Clin. Oncol. 2012; 30: 637-643

SAGB.CAB.16.05.0461a
Date of Preparation: June 2016

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