Zai Lab announces approval of Zejula for patients with relapsed ovarian cancer.
Zai Lab Limited announced that the Hong Kong Department of Health has approved ZEJULA, an oral, once-daily poly polymerase inhibitor in Hong Kong for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete response or partial response to platinum-based chemotherapy. Unlike other PARP inhibitors approved in Hong Kong, ZEJULA does not require BRCA mutation or other biomarker testing prior to administration. The approval of ZEJULA in Hong Kong was based upon the international Phase 3 ENGOT-OV16/NOVA trial sponsored by TESARO, Inc., a double-blind, placebo-controlled study that enrolled 553 patients with relapsed predominantly high grade serous ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by a CR or PR for more than six months to their penultimate platinum-based therapy. The primary endpoint of the trial was progression free survival. 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 both 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 and by 55% in patients without germline BRCA mutations. The magnitude of benefit was similar for patients entering the trial with a CR or PR.
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|Date:||Oct 22, 2018|
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