Real-Time Oncology Review for GSK's Zejula submission
The US regulator has accepted a submission from GlaxoSmithKline (LSE: GSK) to broaden the label for the PARP blocker Zejula (niraparib), to include first-line maintenance treatment for certain women with ovarian cancer.
The indication covers people who responded to platinum-based chemotherapy, regardless of biomarker status.
The submission will be considered under the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) pilot program, which aims to speed up the review process.
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