Bladder Cancer Patients and Doctors Disappointed by Scottish Medicines Consortium's Negative Decision on Javlor® (Vinflunine as Ditartrate) for the Treatment of Adult Patients

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Jul 13, 2015, 09:27 ET

WINCHESTER, England, July 13, 2015 /PRNewswire/ --

Bladder cancer patients and doctors are disappointed by the negative decision from the Scottish Medicines Consortium (SMC) that means people with advanced bladder cancer treated by NHS Scotland will not be offered Javlor® for the treatment of adult patients with advanced or metastatic Transitional Cell Carcinoma of the Urothelial tract (TCCU) after failure of a platinum-containing regime. ^[¹^]^,^[²^]

The negative decision comes despite new real world evidence of survival benefit with Javlor® reported by clinicians using the drug to treat patients in Scotland and England in an expanded access programme.^[³^] Results showed that patients with advanced bladder cancer treated with Javlor® had a median overall survival of 9.5 months.^[³^] This supported the findings from a phase III randomised trial showing a 28% reduction in the relative risk of death of adding Javlor® to best supportive care compared to best supportive care alone.^[⁴^] Similar results in real world experience have been reported in other European countries, including a study in Spain of 102 patients with a median overall survival of 10 months.^[⁵^]

"We are very sad to hear that patients are being denied vinflunine as a treatment for metastatic bladder cancer due to cost. This drug is the only second line treatment that there is for these patients and, whilst the life extending properties are limited, it does give the patient and their family some time," said Andrew Winterbottom from Fight Bladder Cancer, who presented the patient perspective at the SMC Patient and Clinician Engagement (PACE) meeting.^[²^] Fight Bladder Cancer is a charity founded and run by bladder cancer survivors and their families.

Dr Syed Hussain, Clinical Senior Lecturer and Consultant in Medical Oncology at University of Liverpool and Clatterbridge Cancer Centre, said, "As a bladder cancer expert treating a significant number of these patients, I am disappointed to see that vinflunine is not available for carefully selected patients with this disease who may gain survival benefit with this drug. Availability of vinflunine in its licensed indication and in a setting where there is an unmet medical need would help to improve outcome for these patients with metastatic bladder cancer. The treatment window of opportunity for these patients is very small, as at this end-stage of disease patients can deteriorate very rapidly."

Santoke Naal, Managing Director UK Pierre Fabre Ltd., the company that markets Javlor®, said "We are very committed to supporting patients with unmet medical needs to benefit from evidence based therapies that improve their outcomes. We are disappointed that the negative decision by the SMC on Javlor® means patients in Scotland will not have access on the NHS to the only medicine licensed^[⁶^] for the treatment of adult patients with advanced or metastatic TCCU after failure of a platinum-containing regimen. We will continue to work with physicians and patients to help gain access to treatments that will improve survival."

About Javlor®:

Javlor® is a novel tubulin inhibitor, disrupting cell division and promoting cell death.^[⁷^]

Javlor® is indicated as monotherapy for the treatment of adult patients with advanced or metastatic TCCU after failure of a prior platinum-containing regimen. It has not been studied in patients with a performance status of 2 or more.^[⁷^]

A phase III randomised trial in patients progressing after first-line treatment with platinum-containing regimens showed a survival benefit with vinflunine, which was statistically significant in the eligible patient population.^[⁸^] Results showed a manageable safety profile^[⁸^] and a favourable benefit/risk assessment for the EMA.

The most frequent treatment related adverse events are haematological disorders mainly neutropenia and anaemia; gastrointestinal disorders, especially constipation, anorexia, nausea, stomatitis/mucositis, vomiting, abdominal pain, diarrhoea and general disorders such as asthenia/fatigue.^[⁷^]

About bladder cancer:

Bladder cancer is the seventh most common cancer in the UK. It is the fourth most common cancer in the United Kingdom, in men.^[⁹^]

A total of 10,399 people were newly diagnosed with bladder cancer in the UK in 2011, which is equivalent to 28 people every day.^[⁹^]

Transitional cell carcinoma of the urothelial tract is by far the commonest type of bladder cancer, affecting 90% of people with bladder cancer. It develops from the cells of the bladder lining, the urothelium.^[⁹^] The most common symptom of bladder cancer is blood in the urine. The bleeding is usually painless.^[⁹^]

About Pierre Fabre Laboratories:

Pierre Fabre is the 3rd largest French pharmaceutical group and the 2nd largest dermo-cosmetics laboratory in the world. In 2014, its sales reached €2.1 billion, with Dermo-Cosmetics revenues accounting for 55% and international sales for 55%. It was founded in the southwest of France where its headquarters remain even today. Pierre Fabre currently has branches in 44 countries and distribution agreements in over 130 countries.

Covering a continuum of healthcare products, from prescription drugs and consumer health care products (family care, oral care, natural health) to dermo-cosmetics, Pierre Fabre Laboratories employ over 10,000 people worldwide. In 2014, Pierre Fabre dedicated more than 17% of its drug revenues to R&D.

With brands such as Eau thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Galénic, Naturactive, Elgydium, Eludril or Drill, Pierre Fabre Laboratories are market leaders when it comes to skin, hair and oral care products distributed in the French pharmacy channel. Eau thermal Avène is marketed worldwide, and is the leading dermocosmetics brand sold in Europe, Japan and China. In oncology, Pierre Fabre achieves 90% of its revenues outside of its home country.

Through the Pierre Fabre Participations holding company, the Pierre Fabre Foundation, a government-recognized public-interest foundation, owns 86% of Pierre Fabre Laboratories. Remaining shares are owned by company employees, amounting to 7,3 %, and through treasury stock.

The French certification group AFNOR has audited Pierre Fabre Laboratories for its corporate social responsibility (CSR) performance at advanced level (AFAQ 26 000) To find out more, please visit http://www.pierre-fabre.com

About the Pierre Fabre oncology franchise:

The commitment of the Pierre Fabre Group to oncology is large. It is involved in multiple investment opportunities, internally through research activities and externally through partnerships with leading organisations and institutions. The company is currently engaged in over 50 Phase I to Phase IV post marketing clinical trials in cancer patients around the world. Research activities are focused on therapeutic segments with the highest unmet medical needs. Pierre Fabre's goal is to find new treatment approaches for high prevalence tumor types with unacceptable rates of mortality as well as other solid and hematological tumors for which there is currently no optimal care. Priority is also given to patients. R&D activities also concern new product forms that are easier to administer and Pierre Fabre Pharmaceuticals supports patient associations whose aim is to increase patient well-being and help them maintain both the physical and psychological strength they need to fight off their disease.

References

SMC decision document http://www.scottishmedicines.org.uk , Accessed 13/07/2015.
SMC Patient and Clinician Engagement (PACE) http://www.scottishmedicines.org.uk/files/PACE/PACE_factsheet_FINAL.pdf , Accessed 02/06/2015.
Hussain S.A. et al. VICTOR: Vinflunine (Vin) in advanced metastatic transitional cell carcinoma of the urothelium (TCCU)-A retrospective analysis of use of Vin in multicenter, real life setting as second-line chemotherapy (ChT) through free-of charge-programme (FOCP) for patients (pts) in the UK..J Clin Oncol. 2015;33(suppl 7; abstr 352).
Bellmunt J, Fougery R, Rosenberg JE et al. Long-term survival results of a randomized phase III trial of vinflunine plus best supportive care versus best supportive care alone in advanced urothelial carcinoma patients after failure of platinum-based chemotherapy. Annals of Oncology. 2013;25(Supplement 3):iii40-iii48.
Castellano D et al. Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice. BMC Cancer. 2014; 14:779.
Witjes J et al. European Association of Urology (EAU) full guidelines 2015. Available at http://uroweb.org/guideline/bladder - cancer - muscle - invasive - and -metastatic/ , Accessed 02/06/2015.
Javlor® SmPC 2014, https://www.medicines.org.uk/emc/medicine/22762, Accessed 02/06/2015.
Bellmunt J et al. Phase III Trial of Vinflunine Plus Best Supportive Care Compared With Best Supportive Care Alone After a Platinum-Containing Regimen in Patients With Advanced Transitional Cell Carcinoma of the Urothelial Tract. J Clin Oncol. 2009;27(27):4454-61.
Cancer Research UK http://www.cancerresearchuk.org/health - professional/cancer - statistics/statistics - by cancer - type/bladder - cancer, Accessed 02/06/2015.