What's Happening?
Corcept Therapeutics Incorporated has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the European Commission (EC) approve relacorilant, combined with the chemotherapy
drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. This recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials. In these trials, patients who received relacorilant in combination with nab-paclitaxel demonstrated improved progression-free and overall survival compared to those who received nab-paclitaxel alone. The safety profile of the combination therapy was consistent with that of nab-paclitaxel monotherapy. Relacorilant, marketed as Lifyorli® in the United States, is a selective glucocorticoid receptor modulator that is proprietary to Corcept.
Why It's Important?
This positive CHMP opinion is a significant step towards providing a new treatment option for patients with platinum-resistant ovarian cancer in the EU. Ovarian cancer is the fifth most common cause of cancer death in women, and patients with platinum-resistant disease have limited treatment options. Approximately 20,000 women in the United States and at least an equal number in Europe are candidates for new therapies each year for this condition. Cortisol plays a role in tumor growth by inhibiting chemotherapy's tumor-killing effects, promoting tumor growth, and suppressing the immune response. Relacorilant's mechanism of action, by modulating the effects of cortisol, offers a fundamentally new approach to treating this aggressive cancer, potentially improving outcomes for a patient population with high unmet medical needs.
What's Next?
The European Commission will now review the CHMP's positive opinion and is expected to issue a final decision regarding marketing authorization in the fourth quarter of 2026. If approved, Corcept Therapeutics will proceed with making Lifyorli® available to patients in the EU. The company will likely focus on market access strategies and educational initiatives for healthcare providers. This potential approval in Europe follows its existing approval in the United States, indicating a global expansion for this treatment. Corcept will also continue its advanced development programs for other disorders by modulating cortisol, including hypercortisolism, various solid tumors, ALS, and liver disease.
Beyond the Headlines
The potential approval of Lifyorli® highlights the growing understanding of the complex interplay between hormones and cancer progression. Cortisol, often associated with stress, has a significant role in oncology, influencing tumor resistance to chemotherapy and immune suppression. Targeting the glucocorticoid receptor with selective modulators like relacorilant represents an innovative strategy in cancer therapy, moving beyond traditional chemotherapy and immunotherapy. This approach could open new avenues for treating other cancers where cortisol pathways are implicated. Furthermore, the success of this drug underscores the importance of academic and industry collaborations, as the ROSELLA trial was conducted in partnership with several international gynecological oncology groups, demonstrating the power of global research efforts in advancing cancer care.
