Lifyorli (relacorilant) + nab-paclitaxel for platinum-resistant ovarian cancer: what changed after FDA approval
On March 25, 2026, the FDA approved Lifyorli (relacorilant) in combination with nab-paclitaxel for treating adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior lines of systemic therapy, with at least one regimen containing bevacizumab. This approval was based on the ROSELLA trial.
Key trial data
The FDA approval is based on the ROSELLA trial, which enrolled 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients were randomized to receive Lifyorli (relacorilant) + nab-paclitaxel or nab-paclitaxel alone.
- Median progression-free survival was 6.5 months vs 5.5 months
- Median overall survival was 16.0 months vs 11.9 months
- 30% reduction in risk of progression or death (HR 0.70; p=0.0076)
- 35% reduction in risk of death (HR 0.65; p=0.0004)
This is important because in the platinum-resistant setting, an overall survival benefit is particularly valuable. Common adverse events included decreased hemoglobin, neutropenia, fatigue, nausea, diarrhea, thrombocytopenia, rash, and decreased appetite.
Clinical significance
Platinum-resistant ovarian cancer remains one of the most challenging clinical situations. When the disease progresses rapidly, the space for truly effective treatment options becomes narrow. In this context, the Lifyorli (relacorilant) combination is significant because it provides not only a statistical advantage in progression-free survival but also a meaningful improvement in overall survival.
In Western practice, this is now a regulatory-approved new option. Unfortunately, it is not yet registered in Russia.
Limitations
These data apply specifically to platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 lines of treatment and prior bevacizumab use. The regimen is not suitable for patients who require chronic or frequent glucocorticosteroid use, as such patients were excluded from the trial.
If you have platinum-resistant recurrent ovarian cancer and are choosing the next treatment step
Get a second opinionWhen a second opinion is helpful
- If the recurrence has been classified as platinum-resistant but the treatment plan raises questions
- If you are being offered only one drug without discussion of modern combinations
- If bevacizumab was previously used and you need to understand what comes next
- If there are concerns about toxicity risks or limitations due to concomitant therapy
What to prepare for consultation
- Histopathology report
- Discharge summaries for all prior lines of treatment
- Information about whether bevacizumab was used
- Most recent CT, MRI, or PET-CT scans
- Complete blood count and biochemistry panel
- List of comorbidities and current medications, especially steroids
Frequently asked questions
Is this regimen suitable for all patients with recurrent ovarian cancer?
No. This applies specifically to platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 lines of treatment, where at least one line included bevacizumab.
Does the combination improve overall survival?
Yes. In ROSELLA, median overall survival was 16.0 months vs 11.9 months with nab-paclitaxel alone.
Can this regimen be used if the patient requires corticosteroids?
No, this is a specific contraindication in the FDA label.