Reason for request



Clinical Benefit


The Committee deems that the clinical benefit of LYNPARZA (olaparib), monotherapy, remains substantial in the MA indication.

Clinical Added Value


In view of:

  • the evidence of the superiority of olaparib monotherapy versus placebo, in a randomised double-blind study, in terms of investigator-assessed progression-free survival: HR=0.30 [95%CI: 0.23-0.41], with a median progression-free survival not reached in the olaparib group and of 13.8 months in the placebo group,
  • the lack of evidence of superiority on overall survival, despite the new data submitted,
  • the lack of formal conclusion that can be drawn from the quality-of-life findings,
  • the safety profile of olaparib, with in particular the onset of myelodysplastic syndromes/acute myeloid leukaemia,

the Committee deems that LYNPARZA (olaparib) monotherapy provides minor clinical added value (CAV IV) in the therapeutic strategy.

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