Corcept receives positive European recommendation for ovarian-cancer therapy

European drug advisers recommended approval of Corcept’s ($CORT) relacorilant, to be marketed as Lifyorli, in combination with nab-paclitaxel for platinum-resistant ovarian cancer. The positive opinion from the Committee for Medicinal Products for Human Use advances the application to the European Commission, with a decision expected in the fourth quarter.

The submission is supported by Phase 2 and Phase 3 evidence, including the ROSELLA trial, which showed improvements in progression-free and overall survival compared with nab-paclitaxel alone. Corcept said the combination’s safety profile was consistent with the chemotherapy comparator. This is a regulatory recommendation based on the clinical package, not a new European marketing authorization or a guarantee that commercial sales will begin immediately.

Sources:

• Corcept — CHMP opinion and supporting clinical program, Business Wire