CHMP Backs Corcept’s Lifyorli for Ovarian Cancer

The European Medicines Agency's human medicines committee has recommended approval of Lifyorli (relacorilant), from Corcept Therapeutics, for platinum-resistant ovarian cancer — a setting where chemotherapy alone is typically counted in months, not years. The positive opinion, adopted 17 September 2026, points to a Phase 3 trial in which adding relacorilant to standard chemotherapy extended median survival by just over four months.

A mechanism aimed at chemotherapy resistance

Relacorilant is a selective, reversible antagonist of the glucocorticoid receptor — the cellular target of cortisol and other corticosteroids. Corcept's research program is built around the idea that cortisol signaling through this receptor helps tumor cells resist chemotherapy and evade apoptosis, the cell's normal self-destruction pathway; blocking the receptor, in the company's framing, is meant to make chemotherapy work better rather than to act as an anti-cancer therapy on its own. That is why relacorilant is developed and, in this recommendation, indicated strictly as a combination partner alongside nab-paclitaxel, not as a standalone treatment.

The trial behind the opinion

Platinum-resistant ovarian cancer — disease that progresses within six months of finishing platinum-based chemotherapy — is a setting with few effective options and where nab-paclitaxel alone is a common standard. ROSELLA, the pivotal Phase 3 trial (NCT05257408), randomized patients with platinum-resistant, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received one to three prior lines of systemic treatment. The trial's headline result, published in The Lancet, was a median overall survival of 16.0 months on relacorilant plus nab-paclitaxel against 11.9 months on nab-paclitaxel alone — a hazard ratio of 0.65 (95% CI 0.51–0.83, P=.0004), meaning a roughly 35% reduction in the risk of death. Progression-free survival by blinded independent central review favored the combination as well: a median of 6.5 months against 5.5, hazard ratio 0.70 (95% CI 0.54–0.91, P=.0076).

One recommendation among a dozen

Lifyorli was one of twelve new medicines CHMP recommended at its September plenary. The same meeting backed AstraZeneca's Klygefa for generalised myasthenia gravis and Novo Nordisk's Frehemgo for haemophilia A, among others — a reminder that a single CHMP session routinely clears a wide spread of therapeutic areas at once, and that the European Commission's decisions on all of them will land on broadly the same fourth-quarter timeline.

What is not yet decided

A CHMP positive opinion is a scientific recommendation, not marketing authorization. The European Commission makes the legally binding decision for all 27 EU member states, and while it follows CHMP's opinions in the overwhelming majority of cases, the authorization — and the exact terms of the label, including any post-marketing commitments — are not final until that decision issues. Corcept said it expects the Commission's decision in the fourth quarter of 2026; this opinion concerns the EU pathway specifically and does not itself change relacorilant's regulatory status anywhere else.

Frequently asked questions

What did CHMP recommend?

Marketing authorization for Lifyorli (relacorilant), combined with nab-paclitaxel, for adult patients with platinum-resistant, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. CHMP adopted the positive opinion on 17 September 2026, at its 14–17 September plenary.

What is relacorilant?

A selective, reversible glucocorticoid receptor antagonist, from Corcept Therapeutics, marketed under the brand Lifyorli and supplied as 25 mg and 100 mg soft capsules. It is developed as a combination partner for chemotherapy, not a standalone treatment.

What evidence backs the opinion?

The Phase 3 ROSELLA trial: median overall survival of 16.0 months for relacorilant plus nab-paclitaxel versus 11.9 months for nab-paclitaxel alone (HR 0.65, 95% CI 0.51–0.83, P=.0004), and median progression-free survival by BICR of 6.5 versus 5.5 months (HR 0.70, 95% CI 0.54–0.91, P=.0076), published in The Lancet.

When could it reach patients?

A CHMP opinion is a recommendation, not an approval. The European Commission makes the binding EU-wide decision, and Corcept said it expects that decision in the fourth quarter of 2026.