The Committee deems that the clinical benefit of LYNPARZA (olaparib), monotherapy, remains substantial in the MA indication.
Clinical Added Value
minor
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) monotherapyprovides minor clinical added value (CAV IV) in the therapeutic strategy.
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