FDA accepts new drug application of GSK nilaparil for ovarian cancer

GlaxoSmithKline (GSK) announced Thursday that the US FDA has accepted the company's SNDA application for the PARP inhibitor niraparib (English trade name zejula) This application seeks to use nilaparil as a maintenance therapy for patients with advanced ovarian cancer who respond to platinum based chemotherapy in the first line of treatment There is no need to consider the biomarker status of these patients FDA will use the RTOR pilot project to evaluate the application, which is expected to be completed as soon as possible According to the press release, ovarian cancer affects more than 220000 women in the United States, and about 85% of patients with advanced ovarian cancer will relapse After each relapse, the remission period before the next relapse was shortened Nilapari is a PARP inhibitor obtained by GSK in its acquisition of tesaro PARP inhibitors are targeted therapies to kill cancer cells by inhibiting DNA damage repair response (DDR) mediated by PARP Using the "synthetic lethal" principle, they can kill cancer cells without affecting healthy cells This application is based on a clinical trial called prima Experimental data show that as a maintenance therapy, nilaparil provides clinically significant benefits for patients with advanced ovarian cancer The results were presented at the 2019 ESMO conference and published in the New England Journal of medicine The results showed that zejula reduced the risk of disease progression or death by 38% (HR = 0.62, 95% CI, 0.50-0.75, P < 0.001), 13.8 months for PFS in the zejula group and 8.2 months for the control group, regardless of the biomarker status Among them: The risk of BRCA mutation was reduced by 60% (HR = 0.40, 95% CI, 0.27-0.62, P < 0.001) Patients with wild-type BRCA but with HR deficiency had a 50% reduced risk (HR = 0.50, 95% CI, 0.30-0.83, P = 0.006) Patients with normal homologous recombination had a 32% lower risk (HR = 0.68, 95% CI, 0.49-0.94, P = 0.020) In China, nilaparil was developed by zaiding Pharmaceutical Co., Ltd and was approved by the State Drug Administration at the end of last year as a maintenance treatment for adult patients with recurrent epithelial ovarian cancer, salpingocarcinoma or primary peritoneal cancer who were completely or partially relieved by platinum chemotherapy We wish that the review of this innovative therapy can be completed as soon as possible, for the benefit of more patients with ovarian cancer reference material: [1] U.S FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer Retrieved February 24, 2020, from https:// Original title: first line maintenance therapy for ovarian cancer patients by express delivery, FDA accepts the application for new drug supplement of nilaparil A kind of