CHMP recommends EU approval for Lifyorli in ovarian cancer treatment

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the approval of Lifyorli (relacorilant) in combination with nab-paclitaxel. The treatment is intended for patients with platinum-resistant, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have undergone one to three prior therapies.

The recommendation is based on data from the phase 3 ROSELLA trial and a phase 2 study. In the ROSELLA trial, patients receiving the combination therapy showed improved survival outcomes compared to those receiving nab-paclitaxel alone. The median progression-free survival was 6.5 months for the combination group versus 5.5 months for the control group. Additionally, median overall survival reached 16.0 months in the combination arm compared to 11.9 months in the control arm.

Lifyorli has been granted orphan drug status due to the rarity and severity of the targeted cancers. The European Commission is expected to issue a final decision regarding marketing authorization in the fourth quarter of 2026.