On November 14, 2022, at the request of the FDA, Clovis Oncology, Inc. (the "Company") met by teleconference with the FDA to discuss the overall survival (OS) data from the Company’s ARIEL3 clinical trial (Filing, Clovis Oncology, NOV 14, 2022, View Source [SID1234624529]). The ARIEL3 dataset formed the basis for the approval of Rubraca in the US in April 2018 and in Europe in January 2019 respectively, as second-line maintenance treatment in adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The Company submitted final OS data, including in exploratory subgroups, from the ARIEL3 study to the FDA in September 2022. The FDA requested that the Company voluntarily revise the label to limit the indication of Rubraca in this second-line maintenance treatment to tBRCA patients only. The FDA further indicated to the Company that if an agreement could not be reached on the revised indication, the FDA would convene an ODAC meeting to review this matter. The Company is currently evaluating FDA’s request.

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