- ZEJULA is the first PARP inhibitor approved in
Europefor women with recurrent ovarian cancer, without the need for BRCA testing and regardless of biomarker status
- ZEJULA is the only PARP inhibitor to offer once-daily, oral dosing that enables convenient administration for maintenance treatment
- ZEJULA is also currently available for patients in the
UKwho have private insurance TESAROwill continue to make ZEJULA available across Europein 2018
“As we continue to globalize our mission, we remain committed to enabling access to this important therapy for patients who have completed platinum-based chemotherapy and have limited treatment options. In the U.S., where ZEJULA has been approved since March, it is the most frequently prescribed PARP inhibitor for patients with ovarian cancer,” said
The EC approval of ZEJULA was based on data from the clinically rigorous ENGOT-OV16/NOVA trial, a double-blind, placebo-controlled, international Phase 3 study of ZEJULA that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. 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 ratio (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.
In the ENGOT-OV16/NOVA trial, the most common grade 3/4 adverse reactions to ZEJULA included thrombocytopenia (34%), anemia (25%), neutropenia (20%), and hypertension (8%). Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low, approximately 1% after month three. The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3%, 2% and 1% of patients, respectively.
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 events1.
About Ovarian Cancer in
About ZEJULA (niraparib)
ZEJULA is a once-daily, oral poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the
Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in 1.4% of patients receiving ZEJULA vs. 1.1% of patients receiving placebo in the Phase 3 NOVA trial, and 0.9% of patients treated with ZEJULA in all clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Monitor complete blood counts (CBCs) weekly for the first month of treatment and modify the dose as needed. After the first month, it is recommended to monitor CBCs for the next 10 months of treatment, and periodically after this time. Based on individual laboratory values, weekly monitoring for the second month may be warranted.
Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Pre-existing hypertension should be adequately controlled before starting ZEJULA. Monitor blood pressure monthly for the first year and periodically thereafter during treatment with ZEJULA. ZEJULA should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with antihypertensive therapy.
Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the possible 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.
In clinical studies, the most common adverse reactions included: thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, abdominal pain, diarrhea, dyspepsia, urinary tract infection, fatigue/asthenia, decreased appetite, headache, dizziness, dysgeusia, palpitations, insomnia, nasopharyngitis, dyspnea, cough, and hypertension.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
Global Media & Investor Contact:
+1.781.325.1116 or firstname.lastname@example.org
International Media Contact:
Head of Corporate Affairs, International
+41 (0) 41 588 08 68 or email@example.com
1 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
3 EUCAN http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2 (Last accessed
4 ENGAGe, Ovarian Cancer Fact Sheet. https://engage.esgo.org/media/2017/08/ENGAGe_What_is_ovarian_cancer_en_V01.pdf (Last accessed
5 Lorusso, D., Mancini, M.,
Source: TESARO, Inc.