GlaxoSmithKline Says FDA Accepts SNDA Application for Zejula
February 24 2020 - 8:56AM
Dow Jones News
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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