FDA's Recommendation Before Clovis Submits Application For Ovarian Cancer

 

• Earlier this month, Clovis Oncology Inc 
  CLVS-0.46%+ Free Alerts
   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.

https://www.benzinga.com/general/biotech/22/07/27982812/fdas-recommendation-before-clovis-submits-rubraca-application-for-ovarian-cancer