JEVTANA(R) (Cabazitaxel) Is Now Available In The UK For The Treatment Of Men With Advanced Prostate Cancer Resistant To Other Therapy
Sanofi-aventis announced today that it has launched JEVTANA in combination with prednisone/prednisolone for the treatment of men with mHRPC previously treated with docetaxel. Men with this stage of cancer typically have a poor prognosis and until now, there have been no licensed treatments available to extend life.3
JEVTANA is the first licensed agent to significantly extend overall survival in men with mHRPC whose disease has progressed during or after treatment containing docetaxel (15.1 months median overall survival vs. 12.7 months in the control arm; HR=0.70 (95% CI: 0.59-0.83); P<0.0001).1 In clinical trials, JEVTANA was also shown to double the median time before the disease progressed compared with mitoxantrone – 2.8 months versus 1.4 months [HR = 0.74 (95% CI: 0.64-0.86); P<0.0001].1
JEVTANA is a semi-synthetic taxane and has the added benefit of overcoming treatment resistance to the taxanes docetaxel and paclitaxel. It attacks the microtubular structure of cancer cells to inhibit cell division and cause cancer cell death.4
The JEVTANA launch in the UK follows the grant of marketing authorisation from the European Commission in March 2011 for the 27 member states of the European Union, as well as Iceland, Lichtenstein and Norway. The decision to grant marketing authorisation was based on the results from the Phase III TROPIC clinical study involving 755 patients with mHRPC previously treated with docetaxel.
Notes
About the Phase III TROPIC study1
TROPIC was a randomized global study, involving 755 patients from 146 sites in 26 countries. In addition to improving overall survival and progression-free survival, cabazitaxel showed significantly higher physicianassessed tumour response rates of 14.4% versus 4.4% for mitoxantrone (p=0.0005).
More patients in the cabazitaxel group completed treatment than in the mitoxantrone group, with the majority, (at least 75%) receiving more than 90% of the planned dose in cabazitaxel treatment. The most frequent grade 3/4 haematological adverse events (AEs) with cabazitaxel included neutropenia, febrile neutropenia and anaemia – (rates of neutropenia in both arms may have been higher because of the stage of disease and prior docetaxel treatment.) Other side effects included diarrhoea, nausea and fatigue. Most frequent treatmentemergent AEs leading to discontinuation in the cabazitaxel arm were neutropenia (2.4%), haematuria (1.3%), diarrhoea (1.1%) and fatigue (1.1%). Deaths due to AEs were 4.9% in the cabazitaxel arm (predominantly due to neutropenia and its complications) versus 1.9% in the mitoxantrone arm. [The FDA suggests that G-CSF (granulocyte-colony stimulating factor) may be administered to reduce the risk of neutropenia by increasing the production of white blood cells.].
About prostate cancer
Prostate cancer is the most common cancer in British men, affecting around 36,000 every year.5 It is the second most common cause of male cancer deaths, after lung cancer and resulted in over 10,000 deaths in 2008.6 Although most men are diagnosed with early stage disease, as many as 10-50% will progress to develop cancer that spreads to other parts of the body.6 In addition, around 20-30% of men are first diagnosed once the disease has already spread (i.e. metastatic).7
Over time, the majority of men with metastatic prostate cancer will become refractory to hormone therapy, at which point prognosis is poor and survival is unlikely to exceed 9-12 months.3 The aim of treatment at this stage is to prolong survival, slow progression of the disease and improve symptoms.3 It is estimated that metastatic hormone-refractory prostate cancer causes the highest amount of disease-related deaths.3
References
1. de Bono JS et al. Cabazitaxel plus prednisone or mitoxantrone plus prednisone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment. Lancet 2010;376:1147-54
2. JEVTANA Summary of Product Characteristics
3. National Institute for Health and Clinical Excellence. Docetaxel for the treatment of hormone-refractory metastatic prostate cancer. Technology Appraisal 101. London: NICE, 2006
4. Attard G et al. Update on tubulin-binding agents. Pathol Biol (Paris) 2006;54:72-8
5. Cancer Research Research UK. Prostate cancer – key facts. Accessed May 2011. See here.
6. Shelley M et al. Chemotherapy for hormone-refractory prostate cancer (review). Cochrane Library 2008, Issue 4. Accessed May 2011. See here.
7. Cancer Research UK. Prostate Cancer – Symptoms and Treatment. Accessed May 2011. See here.
Source:
Sanofi-aventis