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GlaxoSmithKline : Says FDA Accepts SNDA Application for Zejula

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02/24/2020 | 03:41 pm

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

 

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