Pharma Focus Asia

BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China

Saturday, July 18, 2020

BeiGene, Ltd., a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

“This is our first NDA filing for pamiparib, which was discovered by BeiGene and is being developed as both a monotherapy and in combination with other agents, including our own anti-PD1 antibody, tislelizumab,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “For patients in China with advanced ovarian cancer, we are hopeful that pamiparib can offer a new treatment option. We look forward to presenting the clinical data that supports the NDA filing and additional results, including Phase 3 data, in the upcoming months.” 

This NDA is supported by clinical results from a Phase 1/2 trial of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915). The pivotal Phase 2 portion of the trial enrolled 113 patients in China with high-grade epithelial ovarian cancer (including fallopian or primary peritoneal cancer) or high-grade endometrioid epithelial cancer, harboring germline BRCA1/2 mutation, following at least two prior lines of standard chemotherapy. Patients received pamiparib 60 mg orally twice daily and the primary endpoint of the trial is objective response rate (ORR) by RECIST v1.1. Results of this study will be presented at an upcoming medical conference.

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