Category: (niraparib)

GSK’s Zejula (niraparib) Receives EC’s Approval as a Treatment in Advanced Ovarian Cancer

(niraparib), Advanced, approval, cancer, Clinical Trials, EU, GSK, Ovarian, receives, regulatory, Treatment, Zejula / October 30, 2020 October 30, 2020

Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd …

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GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

(niraparib), 1L, Advanced Ovarian Cancer, approval, GSK, Health Canada, receives, regulatory, Treatment, Women, Zejula / October 6, 2020 October 6, 2020

Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are …

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Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

(niraparib), approval, China, Maintenance Therapy, NMPA, ovarian cancer, patients, receives, Recurrent, regulatory, Zai Lab, Zejula / December 30, 2019 December 30, 2019

Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% …

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China Read More »