This edition presents key opinion leader (KOL) views on recent developments in the ovarian cancer market. Topics covered include: US Food and Drug Administration (FDA) acceptance for Genentech’s supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) and chemotherapy, followed by Avastin alone, in the front-line setting; EU approval of Zejula (niraparib; Tesaro/Merck & Co.) for the treatment of recurrent ovarian cancer, irrespective of BRCA mutation or biomarker status; Clovis’s supplemental New Drug Application (sNDA granted Priority Review in the US ) for rucaparib (Rubraca) as a maintenance therapy for platinum-sensitive, recurrent ovarian cancer and for women showing a complete or partial response to platinum chemotherapy, with no requirement for diagnostic testing.
Business Questions:
- What are KOL’s current views on the amyloid theory of AD?
- What are the KOLs’ opinions on Avastin seeking approval in the front-line setting?
- How is Avastin currently used and how is that going to change following approval as a front-line therapy?
- Do the KOLs believe there any barriers to using Avastin as a front-line treatment?
- What is the reaction from the experts following approval of Zejula, irrespective of BRCA mutation status?
- Is Zejula likely to displace other PARP inhibitors already available on the market for the treatment of ovarian cancer?
- How do the KOLs view the adverse events reported from Phase III trials with Zejula?
- Should Rubraca’s sNDA receive FDA approval, how likely is the drug to gain extensive market share ahead of its competitors?
- What is the view of the experts on having three PARP inhibitors for the treatment of ovarian cancer?
