Chinese regulator accepts NDA of BeiGene’s pamiparib in ovarian cancer

BeiGene said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of pamiparib for the treatment of certain ovarian cancer patients.

Pamiparib is an investigational inhibitor of PARP1 and PARP2 and its NDA is for patients having deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who were treated with two or more lines of chemotherapy.

Yong (Ben) Ben – BeiGene Immuno-Oncology Chief Medical Officer said: “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.

“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.”

According to BeiGene, the NDA is backed by clinical results from a phase 1/2 trial of pamiparib in patients having advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer.

The Chinese biotech company said that the phase 2 part of the trial took in 113 patients in China who have high-grade epithelial ovarian cancer or high-grade endometrioid epithelial cancer, harboring germline BRCA1/2 mutation, following two or more prior lines of standard chemotherapy.

Patients were administered pamiparib 60mg daily twice orally. The primary endpoint of the clinical trial is objective response rate (ORR) by RECIST v1.1.