- Oops!Something went wrong.Please try again later.
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.
See more from Benzinga
Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.