Zai Lab Says China Supplemental New Drug Application for Zejula Accepted
March 16 2020 - 8:21AM
Dow Jones News
By Michael Dabaie
Zai Lab Ltd. said the China National Medical Products
Administration accepted its supplemental new drug application for
Zejula as a maintenance treatment of adults with advanced
epithelial ovarian, fallopian tube, or primary peritoneal
cancer.
The company said the Prima study, conducted by partner
GlaxoSmithKline PLC, demonstrated Zejula treatment resulted in a
38% reduction in the risk of disease progression or death in the
overall study population when compared to placebo. Zejula
demonstrated benefits in all patient subgroups, the company
said.
For patients whose cancer is associated with homologous
recombination deficiency positive status, Zejula treatment resulted
in a 57% reduction in the risk of disease progression or death, Zai
Lab said.
GSK submitted a sNDA to the U.S. Food and Drug Administration
for the use of Zejula in ovarian cancer as first-line maintenance
treatment and the application was accepted in February.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 16, 2020 08:06 ET (12:06 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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