GlaxoSmithKline : Says FDA Accepts SNDA Application for Zejula
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 firstname.lastname@example.org