Zejula shows durable, sustained long-term PFS benefit in first-line platinum-responsive advanced ovarian cancer

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Long-term data from the phase III PRIMA study showing Zejula (niraparib) maintained a sustained and clinically meaningful PFS benefit as a maintenance therapy in patients with first-line ovarian cancer following a response to platinum-based chemotherapy. Importantly, this benefit was sustained across all biomarker subgroups, including BRCAm, HRd and HRp. 

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Companies vying for accelerated approval and devising strategies for confirmatory trials would be best served by seeking prospective sign-off from FDA, agency officials say.  Officials from the FDA Oncology Center of Excellence described these best practices in a perspective piece in the Sept. 21 issue of The New England Journal of Medicine and discussed the...