- Earlier this month, Clovis Oncology Inc 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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