China’s regulatory agency has granted priority review status to BeiGene‘s new drug application (NDA) requesting the approval of pamiparib, its investigational PARP inhibitor, for the treatment of advanced ovarian cancers.
Priority review is granted in China to reduce the time to review and approve promising therapies that address urgent clinical needs.
The NDA specifically covers patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy and carry mutations in the BRCA genes. The priority review status comes days after the Center for Drug Evaluation of China’s National Medical Products Administration agreed to review the application.
“Pamiparib is our third internally developed drug candidate that has been granted priority review in China, following tislelizumab and Brukinsa,” Yong Ben, MD, BeiGene’s chief medical officer, said in a press release. “It received priority review within a week of the acceptance of the application, reflecting the unmet need for patients with this advanced disease.”
Pamiparib (BGB-290) is designed to kill cancer cells by inhibiting the PARP1 and PARP2 DNA repair enzymes, thereby preventing these cells from being able to repair DNA damage. PARP inhibitors are generally more effective in patients whose cancers involve mutations in genes that also affect their ability to repair DNA, such as BRCA genes.
The application of pamiparib was supported by positive data from the pivotal Phase 2 portion of an ongoing Phase 1/2 trial (NCT03333915), involving 113 Chinese patients with high-grade epithelial ovarian cancer or high-grade endometrioid epithelial cancer.
All participants carried mutations in the BRCA1 or BRCA2 genes, and had received at least two prior lines of standard chemotherapy. The main goal is to assess the percentage of patients responding to treatment, as well as the type of responses achieved.
“We look forward to presenting the clinical data that support this NDA at an upcoming medical conference and the next milestones in the pamiparib program,” said Ben.
Beigene is investigating pamiparib for a number of indications, both alone and in combination with standard treatment regimens. An ongoing Phase 3 trial (NCT03519230) in China is testing pamiparib as a maintenance therapy for people with recurrent ovarian cancer who are responding — partially or completely — to their prior platinum-based chemotherapy.
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