TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the National Institute for Health and Care Excellence (NICE) will make ZEJULA®(niraparib), the first PARP inhibitor shown to be effective in patients with a BRCAmutation as well as those without a BRCA mutation, available to women in England and Wales with recurrent platinum-sensitive ovariancancer via the Cancer Drugs Fund (CDF)[1].
NICE has recommended ZEJULA via the CDF for women with a BRCA mutation who have received two lines of chemotherapy and in women without a BRCA mutation who have received two or more lines of chemotherapy.
“At TESARO, we continue to globalize our mission and bring transformative therapies to patients. We are pleased that NICE will now provide more women with recurrent ovarian cancer in England and Wales access to ZEJULA through the CDF,” said Orlando Oliveira, Senior Vice President and General Manager, TESARO International.
“Through close partnership with both NICE and NHS, TESARO can now offer ZEJULA as an option for second-line maintenance treatment, regardless of a patient’s BRCA status.”
The CDF is a source of funding for cancer drugs in England, providing patients access to promising new oncology treatments while NHS England and NICE analyze any additionally requested data to inform a final reimbursement decision on a new treatment or indication.
Overall survival data for ZEJULA are not yet available, and as a result NICE has recommended ZEJULA for use within the CDF while further data are collected[2]. Interim funding is provided via the CDF, giving patients access to the treatment through a managed access arrangement.
“Recurrent ovarian cancer is an aggressive form of cancer where a key goal of treatment is to keep women in remission and off chemotherapy for as long as possible – allowing them the best chance for a good quality of life,” said Jonathan Ledermann, Professor of Medical Oncology at the University College London Cancer Institute.
“ZEJULA offers the chance to delay this cancer from returning or progressing for months, and possibly years in some cases. It is a significant step forward. Crucially, this decision opens the door for many women who, until now, have not had the option of maintenance treatment with a PARP inhibitor.”
About Ovarian Cancer
In the UK, ovarian cancer has the highest mortality rate of all gynecological cancers[3]. It has one of the highest incidence rates in Europe[4] with survival rates among the lowest[5]. The rate of newly diagnosed cases of ovarian cancer in the UK is 16 per 100,000 of the population compared to the European average of 12.6 per 100,0005.Every year 4,100 women lose their lives to ovarian cancer – 11 women every day[6].
The most common symptoms of ovarian cancer include abdominal or pelvic pain, bloating, difficulty eating, and urinary urgency, all of which are commonly associated with less serious conditions. 60% of women with ovarian cancer are diagnosed in an advanced stage[7], when prognosis is poor.
Although significant progress has been made in treatment of ovarian cancer, the disease recurs in approximately 85% of women with advanced ovarian cancer[8], at which point it may be incurable[9],[10]. Recurrent ovarian cancer is the sixth most common cause of cancer death among women and has the highest mortality rate of all gynecological cancers.
References
[1]National Institute for Health and Care Excellence Final appraisal determination. Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer
[2]Cancer Research UK, Ovarian cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer. Accessed May 2018
[3]Cancer Research UK, Ovarian cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer. Accessed May 2018
[4]World Health Organisation. EUCAN ovarian cancer incidence, mortality and prevalence, Available at: http://eco.iarc.fr/EUCAN/CancerOne.aspx?Cancer=27&Gender=2. Accessed May 2018
[5]OCAM, Facts and figures. Available at http://ocam.org.uk/ovarian-cancer-facts-and-figures/. Accessed May 2018
[6]Cancer Research UK, Ovarian cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer Accessed May 2018
[7]ENGAGe. ESGO. Ovarian cancer factsheet. what is ovarian cancer? Available at: https://engage.esgo.org/media/2017/08/ENGAGe_What_is_ovarian_cancer_en_V01.pdf. Accessed April 2018.
[8]Lorusso D, Mancini M, Di Rocco R, Fontanelli R, & Raspagliesi F. The role of secondary surgery in recurrent ovarian cancer. Int J Surg Oncol 2012; doi: 10.1155/2012/613980
[9]Chien J, Kuang R, Landen C, et al. Platinum-sensitive recurrence in ovarian cancer: the role of tumor microenvironment. frontiers in oncology. 2013;3:article 251.
[10]Birrer M, Fujiwara K. Medical treatment for relapsed epithelial ovarian, fallopian tubal, or peritoneal cancer: platinum-resistant disease. 2016. Available at: https://www.uptodate.com/contents/medical-treatment-for-relapsed-epithelial-ovarian-fallopian-tubal-or-peritoneal-cancer-platinum-resistant-disease. Accessed April 2018.
[11]Wang J et al. The Exposure-Response Relationship of Niraparib in Patients with gBRCAmut and Non-gBRCAmut: Results from the ENGOT-OV16/NOVA Trial. ESMO; 2017 Sep 8-12; Madrid, Spain.
