Posted by Michael Wonder on 24 Feb 2020
U.S. FDA accepts GSK’s application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer
24 February 2020 - Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status.
GlaxoSmithKline today announced that the U.S. FDA accepted the company’s submission of a supplemental new drug application seeking approval of Zejula (niraparib) 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 application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
