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Health Canada Health products

ZEJULA (niraparib) - Update on the Maintenance Treatment in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in the Second or Later Line Setting

Issued February 16, 2023
Issue
Currently available data from the NOVA study, based on a data cut-off date of October 1, 2020, shows that the median OS may be lower with ZEJULA compared to placebo for patients in the overall non-g BRCA mut cohort and the non-g BRCA mut / Homologous Recombinant Deficient (HRd) subgroup. GSK has notified Health Canada of additional OS data that will be submitted. Health Canada will review all available OS data and further communicate if any actions are needed.
Hazard description
New safety information
Product
Product name
ZEJULA (niraparib)
Reference
ID
RA-72726