ZEJULA was approved by the
“ZEJULA was studied with the highest level of clinical rigor, and the Phase 3 NOVA trial generated unsurpassed efficacy results in patients with recurrent ovarian cancer, including women without germline BRCA mutations who have the most challenging prognosis and few treatment options,” said
The ZEJULA marketing authorization application is supported by data from the 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. Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased progression free survival (PFS) in patients with and 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 (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 most common grade 3/4 adverse reactions to ZEJULA in the NOVA trial included thrombocytopenia (34%), anemia (25%), neutropenia (20%), and hypertension (9%). Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately 1% after month two. The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively.
“This is an important milestone for
About Ovarian Cancer in
About ZEJULA (niraparib)
ZEJULA is an oral, once-daily poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated in the U.S. for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The National Comprehensive Cancer Network (NCCN) added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017—April 12, 2017—as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of two or more lines of platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding
2 EUCAN (EU, EEA and
3 EUCAN. http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2 (Last accessed
4 CDC, https://www.cdc.gov/cancer/ovarian/statistics/index.htm (Last accessed
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