Zai Lab Says China Supplemental New Drug Application for Zejula Accepted

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 [e-mail]

(END) Dow Jones Newswires

March 16, 2020 08:06 ET (12:06 GMT)

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