CHMP bemærkede, at den pivotale undersøgelse, JHQJ, fokuserede på at påvise forskelle i TtDP ved samlet overlevelse, og at den pivotale undersøgelse vedrørende ovariecancer havde en specifik population bestående af platinsensitive patienter med en meget dårlig prognose.
The CHMP noted the pivotal study JHQJ was powered to detect differences in TtDP in overall survival and that the pivotal study for the ovarian cancer had a specific population consisting of platinum sensitive patients with a very poor prognosis and the CHMP was of the opinion that the proposed wording was in accordance with the submitted study for the marketing authorisation in this indication.