- Inclusion in the
Cancer Drugs Fundwill give more women in Englandand Waleswith recurrent, platinum-sensitive ovarian cancer access to ZEJULA via a managed access arrangement
- ZEJULA was launched in the private market in the
UKat the end of 2017
“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
The CDF is a source of funding for cancer drugs in
“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
About Ovarian Cancer
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 stage7, 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 cancer8, at which point it may be incurable9,10. Recurrent ovarian cancer is the sixth most common cause of cancer death among women and has the highest mortality rate of all gynecological cancers.
About ZEJULA® (niraparib)
Niraparib is marketed in
ZEJULA is approved in
The primary endpoint of the trial was progression free survival (PFS). Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by a robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with or without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (hazard ration (HR) 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.
The approved starting dose of ZEJULA is 300 milligrams once per day. According to the European summary of product characteristics (SmPC), in patients below 58 kilograms, a starting dose of 200 milligrams once per day may be considered. The most commonly administered dose of ZEJULA over the course of the Phase 3 NOVA clinical trial was 200 milligrams once per day, following dose modification. Further exploratory analyses of the NOVA study indicated that individual dose modification maintained efficacy and reduced the rate of new adverse events.11
ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.
Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.
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4 World Cancer Research Fund Initiative. Ovarian cancer statistics, Available at: https://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/ovarian-cancer-statistics. Accessed
5 OCAM, Facts and figures. Available at http://ocam.org.uk/ovarian-cancer-facts-and-figures/. Accessed
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
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
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.
Source: TESARO, Inc.