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Association details:
| Biomarker: | BRCA1 mutation |
|---|---|
| Cancer: | Peritoneal Cancer |
| Drug: | Partruvix (pamiparib) (PARP inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
China NMPA Approves PARP Inhibitor Pamiparib for Patients with Previously Treated Advanced Ovarian Cancer
Published date:
05/07/2021
Excerpt:
BeiGene...announced that its PARP inhibitor pamiparib has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRCA (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.
Trial ID:
Source:
Title:
Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China
Published date:
07/27/2020
Excerpt:
BeiGene...announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, 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...The NDA of pamiparib as a potential treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer was accepted in July 2020. It is supported by clinical results from the pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915)...
Source:
Title:
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
Excerpt:
...2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4....
Trial ID:
