ELAHERE (mirvetuximab soravtansine) - Epithelial ovarian

The clinical benefit provided by ELAHERE 5 mg/mL (mirvetuximab soravtansine) concentrate for solution for infusion is
substantial in the MA indication.

Considering:

• evidence of a superiority of mirvetuximab soravtansine compared to single-agent chemotherapies, in a randomised, open-label, phase 3 trial in terms of:
  • progression-free survival in the ITT population: HR = 0.65; CI95% [0.52; 0.81]; p < 0.0001; with a median progression-free survival of 5.62 months in the mirvetuximab soravtansine group versus 3.98 months in the chemotherapies group;
  • overall survival in the ITT population: HR = 0.67; CI95% [0.50; 0.88]; p= 0.0046; with a median overall survival of 16.5 months in the mirvetuximab soravtansine group versus 12.7 months in the chemotherapies group.
• the lack of demonstrated superiority on abdominal/gastrointestinal symptoms;
• the absence of any formal conclusion that can be drawn based on the quality of life findings;
• the safety profile of mirvetuximab soravtansine deemed to be acceptable compared to single-agent chemotherapy but marked, in particular, by a high incidence of ocular adverse reactions. The EMA qualifies this risk as an important potential risk in the risk management plan for this medicinal product;

the Committee deems that ELAHERE 5 mg/mL (mirvetuximab soravtansine) concentrate for solution for infusion provides a minor clinical added value (CAV IV) compared to single-agent chemotherapy.