FDA accepts new drug application for zejula, an oral PARP inhibitor, submitted by glaxoSmithKline
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, GlaxoSmithKline (GSK) announced that the UsThe FDA(http://has accepted its submitted supplementtolynew drug(http://application (http:// and will review it as a priority for PDUFA on October 24, 2019The sNDA application approved Niraparib for the treatment of patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancerThe submission is based on two studies of QUADRA,of thetrial(http:// published in the Lancet Oncology journalon quadRA
QUADRA is a one-arm, open label trial that assesses the safety and activity of niraparib in patients with recurrent, high-level plasma epithelial ovarian cancer, fallopian tubes, or primary peritoneal cancerThe patient took 300mg of niraparib orally once a day until the condition progressedthe experimental efficacyanalysis (http:// showed that 13 (28%) of the 47 patients received the overall effect, the median non-progressive survival was 5.5 months, and the median reaction duration was 9.2 months If approved, niraparib would be the only drug in the
of the PARP inhibitor class drug (http:// to treat specific indications Such drugs include AstraZeneca and Lynparza in Mersadon, and Rubracar in Clovis Oncology Although Lynparza and Rubracar were also approved for BRCA-positive patients who had undergone multiple rounds of chemotherapy, they did not apply to patients with HRD
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