GSK CEO Emma Walmsley (Fang Zhe/Xinhua/Alamy Live News)

GSK pulls an­oth­er can­cer in­di­ca­tion for Ze­ju­la at FDA's re­quest

GSK said Fri­day morn­ing that, at the re­quest of the FDA, it will re­strict the sec­ond-line main­te­nance in­di­ca­tion for Ze­ju­la (ni­ra­parib) to on­ly cer­tain can­cer pa­tients with dele­te­ri­ous or sus­pect­ed dele­te­ri­ous germline BR­CA mu­ta­tions (gBR­CA­mut).

The move comes as the FDA re­cent­ly an­nounced and then can­celed an ODAC meet­ing for lat­er this month to re­view this in­di­ca­tion.

GSK said in a state­ment that the de­ci­sion is based on the FDA’s re­view of the fi­nal over­all sur­vival analy­sis of the Phase III tri­al that led to this ap­proval in the sec­ond-line main­te­nance in­di­ca­tion for adult pa­tients with ad­vanced ep­ithe­lial ovar­i­an, fal­lop­i­an tube or pri­ma­ry peri­toneal can­cer. In the fi­nal re­sults from the tri­al, the sec­ondary end­point of OS demon­strat­ed a haz­ard ra­tio (HR) of 1.06 (95% CI: 0.81-1.37) in the non-gBR­CA­mut co­hort.

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