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FDA's Recommendation Before Clovis Submits Rubraca Application For Ovarian Cancer

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  • Earlier this month, Clovis Oncology Inc (NASDAQ: CLVS) had a Type A meeting with the FDA to discuss its plans for a supplemental marketing application for Rubraca (Rucaparib) as a first-line maintenance treatment in ovarian cancer.

  • The application, covering patients who have responded to first-line platinum-based chemotherapy, is based on the monotherapy portion of the ATHENA Phase 3 trial.

  • The FDA recommends that the company wait for more mature overall survival data to submit the application.

  • If the company chooses to submit the application before receiving more mature overall survival data, it may need to be discussed at an Oncologic Drugs Advisory Committee meeting.

  • In addition, FDA will consider overall survival data from other rucaparib trials when it reviews the ATHENA-MONO dataset.

  • Clovis intends to submit the supplemental application in Q3 of 2022 to FDA and European Medicines Agency.

  • Price Action: CLVS shares are up 1.83% at $2.22 during the premarket session on the last check Thursday.

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