News|Articles|March 25, 2026

Lifyorli Combo Approved in Platinum-Resistant Ovarian Cancer

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Key Takeaways

FDA authorization covers platinum-resistant disease after 1–3 prior lines, with mandatory prior bevacizumab exposure, positioning glucocorticoid receptor antagonism as a new mechanistic option.
ROSELLA demonstrated PFS 6.5 vs 5.5 months (HR 0.70) and OS 16.0 vs 11.9 months (HR 0.65) favoring relacorilant plus nab-paclitaxel.
Trial architecture was multicenter, open-label, 381 patients randomized 1:1; chronic or frequent glucocorticoid users were excluded, with co-primary endpoints of PFS and OS.
Dosing pairs relacorilant 150 mg PO day −1/0/+1 with nab-paclitaxel 80 mg/m² IV days 1, 8, 15 of a 28-day cycle until progression/toxicity.
Safety profile features cytopenias and infection risk, adrenal insufficiency, and embryo-fetal toxicity; common AEs included anemia, neutropenia, fatigue, GI toxicity, thrombocytopenia, rash, and anorexia.

FDA approved Lifyorli plus Abraxane, improving survival in platinum-resistant ovarian, fallopian tube and peritoneal cancers.

The U.S. Food and Drug Administration has approved Lifyorli (relacorilant) in combination with Abraxane (nab-paclitaxel) on March 25, 2026, for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatments, including bevacizumab, offering a new option for patients with cancer whose disease has progressed after prior therapy.

What data support Lifyorli plus Abraxane in ovarian cancer?

The approval was based on results from the ROSELLA trial, which showed improvements in both progression-free survival and overall survival for patients treated with Lifyorli plus Abraxane compared with Abraxane alone.

Median progression-free survival was 6.5 months in patients who received the combination compared with 5.5 months in those who received Abraxane alone. The hazard ratio was 0.7, meaning patients who received the combination had a 30% lower risk of their cancer growing or spreading during the study period compared with those who received Abraxane alone.

Median overall survival was 16 months in the combination group compared with 11.9 months in the Abraxane group. The hazard ratio for overall survival was 0.65, meaning patients who received the combination had a 35% lower risk of death during the study period compared with those who received Abraxane alone.

In an interview with CURE, Dr. Alexander B. Olawaiye, director of Gynecologic Cancer Research at Magee-Womens Hospital of UPMC, stated, "The ROSELLA trial showed that we can modulate the steroid receptor pathway, specifically the glucocorticoid receptor, and gain benefit in the treatment of platinum-resistant ovarian cancer. This is the first time this has ever been shown in cancer, and particularly in ovarian cancer, because of the uniqueness of the pathway. This is very new in every way you can imagine. That’s number one."

These findings showed that adding Lifyorli to Abraxane helped delay disease progression and helped patients live longer in this setting.

How was the ROSELLA trial designed?

ROSELLA (NCT05257408) was a multicenter, open-label trial that enrolled 381 patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. All patients had previously received up to three lines of systemic therapy and were required to have prior treatment with bevacizumab.

Patients were randomly assigned in a 1:1 ratio to receive either Lifyorli in combination with Abraxane or Abraxane alone. The trial excluded patients who required chronic or frequent use of glucocorticoids.

The main outcomes measured in the trial were progression-free survival and overall survival.

For treatment administration, Lifyorli is given at a dose of 150 mg taken by mouth once on the day before, the day of and the day after each Abraxane infusion. Abraxane is given at 80 mg/m² as an intravenous infusion on days 1, 8 and 15 of each 28-day cycle. Treatment continues until disease progression or unacceptable toxicity.

The FDA noted that the application for this approval was completed 2.5 months ahead of the agency’s goal date using the Assessment Aid, a voluntary submission designed to support the review process.

What side effects are linked to Lifyorli treatment?

The prescribing information for Lifyorli includes a contraindication for patients who require corticosteroids for a lifesaving indication.

Warnings and precautions include risks of neutropenia and severe infections, adrenal insufficiency, worsening of conditions treated with glucocorticoids and embryo-fetal toxicity.

The most common side effects, occurring in 20% or more of patients, included decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash and decreased appetite.

Patients and caregivers are encouraged to speak with their care team about potential side effects and to report any new or worsening symptoms during treatment.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.