ORGOVYX (relugolix) - Advanced hormone-sensitive prostate cancer

The clinical benefit of ORGOVYX (relugolix) 120 mg film-coated tablets is substantial in the MA indication.

Considering:

• demonstration of a non-inferiority of relugolix compared to leuprorelin:
  • on an acceptable endpoint, which is the achievement and maintenance of androgen suppression;
  • in a study context favourable to treatment compliance;
• the safety profile, which is deemed to be acceptable versus clinically relevant comparators;

and despite:

• the open-label nature of the HERO study leading to an assessment and follow-up bias, whereas double-blinding was feasible;
• the inclusion of a heterogeneous population with, in particular, more than a third of the patients included not corresponding to the scope of the MA (28.0% localised form and 9.8% not
  classifiable) i.e. advanced hormone-sensitive prostate cancer, grouping together metastatic and locally advanced stages;
• the absence of an efficacy analysis performed in the study subpopulation corresponding to the MA, i.e. patients with advanced hormone-sensitive prostate cancer;
• the profile of the patients with a metastatic form included in the HERO study, which does not correspond to those immediately treated in current clinical practice with the combination of a GnRH agonist or antagonist (androgen deprivation) with second-generation hormone therapy (only enzalutamide could be added during the study in the event of PSA progression);

the Committee deems that ORGOVYX (relugolix) 120 mg film-coated tablets provide no clinical added value (CAV V) in the current care pathway.