24th Feb 2020 15:42
(Alliance News) - Brentford-based pharmaceutical giant GlaxoSmithKline PLC said Monday the US Food & Drug Administration has accepted its submission of a supplemental new drug application for Zejula.
The application is for the use of Zejula, also known as niraparib, as a maintenance treatment in women with advanced ovarian cancer which responded to platinum-based chemotherapy regardless of biomarker status.
The new drug application was based on results from the PRIMA study, which demonstrated clinically-meaningful outcomes from Zejula treatment.
Zejula is already approved in the US as a maintenance treatment for women with recurrent ovarian cancer who are in response to platinum-based chemotherapy regardless of BRCA mutation status.
Shares in Glaxo were down 1.2% at 1,628.20 pence on Monday in London.
By Dayo Laniyan; [email protected]
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