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NICE recommends Jevtana® (cabazitaxel) to treat eligible patients with advanced prostate cancer

Date: May 25, 2016

Oxford, UK. ­– Sanofi Genzyme, the specialty care global business unit of Sanofi, today announced that Jevtana® (cabazitaxel) has been recommended for use in combination with prednisone or prednisolone as a treatment option for metastatic hormone-relapsed prostate cancer (mHRPC) in England following a review by the National Institute for Health and Care Excellence (NICE).1 This is positive news for patients with advanced prostate cancer as Jevtana® fulfils an important unmet need and has been proven to extend survival for these patients.2

NICE guidance (TA391) published today acknowledges that Jevtana® (cabazitaxel) is both a clinically-effective and cost-effective treatment that prolongs life and is valued by patients.1

“I am delighted with this announcement from NICE, which represents an important milestone for men with advanced prostate cancer”, said Nick James, Professor of Clinical Oncology at the Cancer Centre at Queen Elizabeth Hospital in Birmingham. “It means that patients will now have access to another effective treatment, which may offer extended survival to patients who have failed on other treatments.”

Prostate cancer is currently the most common cancer in men and kills about 10,500 men in the UK every year.3 In time, most prostate cancers become resistant to hormone therapy and continue to grow despite treatment.4 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

NHS Wales and Health and Social Care (HSC) Northern Ireland are expected to adopt NICE guidance. Jevtana® (cabazitaxel) is being appraised by the Scottish Medicines Consortium (SMC) through their Health Technology Appraisal (HTA) process. Guidance in Scotland is expected to be published by the SMC in June 2016.

“We believe that every man with advanced prostate cancer should have access to the treatments that works best for them and their needs,” commented Hugh Gunn, spokesperson for patients’ charity TACKLE Prostate Cancer. “This recommendation provides an important treatment for patients who are in the latter stages of the disease and who have few therapeutic options.”

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 newly published guidance from NICE on the use of Jevtana® (cabazitaxel) in the NHS in England and Wales 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

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 is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

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 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/resources/cabazitaxel-for-hormonerelapsed-metastatic-prostate-cancer-treated-with-docetaxel-82602905134021 [Accessed May 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 Tackle Prostate Cancer. The Prostate and Prostate Cancer – Some facts http://www.tackleprostate.org/some_facts.php [Accessed May 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

Contacts:
Media Relations
Stefanie Holman
Sanofi Genzyme UK & Ireland
Tel.: 01865 405 200 or 07740 935 273
stefanie.holman@sanofi.com

SAGB.CAB.16.05.0461
Date of Preparation: May 2016

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Genzyme Therapeutics Ltd
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Tel: +01865 405200
Fax: +01865 774172
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