News Report · Oncology

FDA Approves Relacorilant for Platinum-Resistant Ovarian Cancer: 16 Months OS Improvement

June 13, 2026

Clinical Perspective

Oncologists treating adults with platinum-resistant ovarian cancer may consider using relacorilant in combination with nab-paclitaxel for patients who have received one to three prior systemic therapies, including bevacizumab. The data supports a median overall survival improvement of 34% with this combination therapy. What additional insights can be gained from ongoing studies regarding long-term outcomes?

Dr. Meera Pillai · Oncology

Relacorilant (Lifyorli) in combination with nab-paclitaxel improved overall survival by 34% versus nab-paclitaxel alone in adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, including bevacizumab (HR 0.65; 95% CI 0.51-0.83) ^[1].

Clinical Context

Platinum-resistant ovarian cancer is a challenging condition characterized by the recurrence of cancer after initial treatment with platinum-based chemotherapy, affecting a significant number of patients. Current treatment options are limited, particularly for those who have already undergone multiple lines of therapy. The standard of care often includes chemotherapy agents like nab-paclitaxel, but many patients experience disease progression. The approval of relacorilant, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel aims to address this unmet need by providing a new therapeutic option for patients who have limited alternatives after prior treatments.

Key Findings

The ROSELLA trial showed relacorilant reduced overall survival by 34% versus nab-paclitaxel alone (HR 0.65; 95% CI 0.51-0.83) ^[1].
The trial enrolled 381 adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer ^[1].
Event rates: 16 months median OS with relacorilant plus nab-paclitaxel versus 11.9 months with nab-paclitaxel alone ^[1].
The primary endpoint was overall survival (OS) ^[1].
Secondary endpoint results showed median progression-free survival (PFS) of 6.5 months with relacorilant versus 5.5 months with nab-paclitaxel alone (HR 0.70; 95% CI 0.54-0.91) ^[1].
Relacorilant is administered at a dose of 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity ^[1].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Decreased hemoglobin reported with relacorilant — exact frequency not available in public source summary ^[1].
Decreased neutrophils reported — exact frequency not available in public source summary ^[1].
Fatigue reported with relacorilant ^[1].
Nausea reported with relacorilant ^[1].
Diarrhea reported with relacorilant ^[1].
Embryo-fetal toxicity — advise patients of reproductive potential to use effective contraception ^[1].
Complete adverse event profile available in the full prescribing information for Lifyorli ^[1].

Study Design

The ROSELLA trial was a multicenter, open-label study that randomized 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer to receive either relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone. The primary endpoint was overall survival, with a follow-up duration sufficient to assess the efficacy outcomes. The trial was funded by Corcept Therapeutics, and key limitations include the open-label design and the exclusion of patients requiring chronic glucocorticoid use. Further data on long-term benefits and quality of life measures are still pending.

FAQ

What is relacorilant (Lifyorli) approved for?

Relacorilant (Lifyorli) is approved for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer on March 25, 2026, based on the ROSELLA trial showing improved overall survival compared to nab-paclitaxel alone.

How does relacorilant work?

Relacorilant is a glucocorticoid receptor antagonist that works by blocking the effects of glucocorticoids, which can promote cancer cell survival and proliferation.

What is the recommended dose of relacorilant?

The recommended dose of relacorilant is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. Clinicians should consult current prescribing information for full dosing guidance.

What are the most common side effects of relacorilant?

The most common side effects of relacorilant include decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, and embryo-fetal toxicity.

How does relacorilant compare to nab-paclitaxel?

In the ROSELLA trial, relacorilant in combination with nab-paclitaxel showed a median overall survival of 16 months compared to 11.9 months with nab-paclitaxel alone.

Who qualifies for relacorilant treatment?

Patients eligible for relacorilant treatment are adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, including at least one with bevacizumab.

References

FDA — FDA approves relacorilant with nab-paclitaxel for platinum-resistant

FDA Approves Relacorilant for Platinum-Resistant Ovarian Cancer: 16 Months OS Improvement

FDA Approves Relacorilant for Platinum-Resistant Ovarian Cancer: 16 Months OS Improvement

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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