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Name | Symbol | Market | Type |
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GSK plc | NYSE:GSK | NYSE | Depository Receipt |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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0.23 | 0.53% | 43.58 | 43.68 | 43.27 | 43.58 | 4,048,068 | 01:00:00 |
By Michael Dabaie
GlaxoSmithKline PLC said the U.S. Food and Drug Administration accepted the company's submission of a supplemental New Drug Application for Zejula as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.
The FDA is reviewing the sNDA under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure treatments are available to patients as early as possible.
GlaxoSmithKline said the application is supported by data from the Prima study, which demonstrated clinically-meaningful outcomes of niraparib treatment in the first-line maintenance setting.
Zejula is currently approved in the U.S. as a maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutation status. It is also approved as a treatment for women with advanced ovarian cancer, following three or more chemotherapy regimens.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
February 24, 2020 09:41 ET (14:41 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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