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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| Gsk Plc | LSE:GSK | London | Ordinary Share | GB00BN7SWP63 | ORD 31 1/4P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| -3.00 | -0.18% | 1,637.50 | 1,637.00 | 1,637.50 | 1,647.00 | 1,634.00 | 1,638.50 | 731,891 | 13:21:09 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| Pharmaceutical Preparations | 30.33B | 4.93B | 1.1970 | 13.70 | 67.52B |
From Apr 2019 to Apr 2024
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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