New FDA-approved treatment for drug-resistant ovarian cancers to improve survival

The US Food and Drug Administration (FDA) has approved a new drug combination for adults with ovarian, fallopian tube or primary peritoneal cancers whose cancers have developed resistance to standard, platinum-based chemotherapy.

The drug relacorilant - brand name Lifyorli - in combination with nab-paclitaxel chemotherapy is now approved for use in the US following positive results from a Phase 3 clinical trial, which showed the combination improved both progression-free survival and overall survival.

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When standard chemotherapy stops working

Platinum-based chemotherapy, like carboplatin, plays a critical role in epithelial ovarian cancer treatment, and most patients initially respond well. However, some will eventually experience a recurrence, and when the cancer returns within six months of their last platinum dose, it is classified as “platinum resistant” - meaning platinum-based drugs are unlikely to work.

Treatment options for platinum-resistant ovarian cancer are limited. Patients in this setting usually receive chemotherapy with or without a targeted cancer therapy, bevacizumab (Avastin). While these treatments can slow disease progression, median overall survival has remained at roughly 10 to 16 months. Researchers have been working to find new approaches that can improve outcomes for this group of patients, and relacorilant represents one such advance.

How does relacorilant work?

When the body is stressed, it produces a hormone called cortisol. Cortisol acts on cells throughout the body by binding to what's known as the glucocorticoid receptor - a protein on the surface of cells that receives cortisol's signals. In ovarian cancer, this signalling can help cancer cells survive chemotherapy, making treatment less effective. Higher levels of this receptor activity have also been linked to poorer outcomes.

Relacorilant is a new type of drug that blocks the glucocorticoid receptor, preventing cortisol from protecting cancer cells. By doing so, it makes the tumour more sensitive to chemotherapy.

It is combined with nab-paclitaxel, a form of the chemotherapy drug paclitaxel packaged with a protein called albumin. Nab-paclitaxel is a particularly suitable because unlike standard paclitaxel it does not require patients to take corticosteroids beforehand - which would counteract the biological mechanism of relacorilant.

What did the clinical trial show?

The approval was based on results from the Phase 3 ROSELLA clinical trial, an international study conducted at 117 sites across 14 countries including Australia. The trial enrolled 381 patients with platinum-resistant ovarian cancer who had received up to three prior lines of treatment, all of whom had previously received bevacizumab.

Patients were randomly assigned to receive either relacorilant plus nab-paclitaxel, or nab-paclitaxel alone. The trial had two main outcomes to measure: progression-free survival (the time before the cancer worsened) and overall survival (the time patients lived after starting treatment).

Key findings of the trial:

Median progression-free survival improved from 5.5 to 6.5 months
The relative risk of death was reduced by 35%
Median overall survival improved from 11.9 to 16 months - a difference of approximately four months

These results are notable in platinum-resistant ovarian cancer, where meaningful improvements in survival have been very difficult to achieve. Over the past decade, many large clinical trials have tested new drug combinations in this setting without success. Until now, bevacizumab was the only drug shown to improve outcomes when added to a chemotherapy like paclitaxel, in the AURELIA trial more than a decade ago.

This treatment also does not require any biomarker testing, meaning all eligible patients with platinum-resistant disease can be considered for treatment, regardless of tumour biology.

A step towards better treatment options for platinum-resistant ovarian cancer

The approval of this new treatment regime is a meaningful addition to the treatment landscape for platinum-resistant ovarian cancer. Together with the recent approval of pembrolizumab for selected patients, it signals real momentum in expanding options for people living with this disease.

Researchers are also investigating whether adding bevacizumab to the relacorilant and nab-paclitaxel combination could provide additional benefit. This triple combination is being explored in an ongoing clinical trial (NCT06906341).

What this means for Australia

The FDA approval is an important regulatory milestone, however, it does not automatically mean the treatment is available or subsidised in Australia.

For relacorilant to be accessible in Australia, it first needs to be approved by the Therapeutic Goods Administration (TGA). For subsidised funding, a listing on the Pharmaceutical Benefits Scheme (PBS) would be required. At this stage, the regulatory timeline in Australia is yet to be confirmed.

Patients seeking access to medicines not yet approved in Australia may be able to do so through the TGA's Special Access Scheme (SAS), which allows doctors to apply to import or supply therapeutic goods that are not yet registered on the Australian Register of Therapeutic Goods (ARTG).

If you or a loved one would like to understand whether this treatment may be relevant in future, speak with your treating specialist. They can provide advice based on your individual diagnosis, treatment history, and available options, including active clinical trials.

References

ClinicalTrials.gov. Relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (ROSELLA). NCT05257408. https://clinicaltrials.gov/study/NCT05257408
FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. FDA. March 25, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
Olawaiye AB, Gladieff L, O’Malley DM, et al. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet 2025; 405: 2205–16. https://doi.org/10.1016/S0140-6736(25)01040-2

Key terms

Bevacizumab (Avastin): A targeted therapy drug that works by blocking the growth of new blood vessels that tumours need to grow and spread.

Food and Drug Administration (FDA): The United States government agency responsible for approving new medicines and treatments.

Nab-paclitaxel: A form of the chemotherapy drug paclitaxel packaged with a protein called albumin, which helps deliver the drug to tumour cells.

Overall survival (OS): The length of time a patient lives after starting treatment.

Pharmaceutical Benefits Scheme (PBS): The Australian Government program that subsidises the cost of approved medicines, making them more affordable for patients.

Platinum resistant: When ovarian cancer returns within six months of completing platinum-based chemotherapy, indicating that platinum drugs are unlikely to be effective again.

Progression-free survival (PFS): The length of time during and after treatment that the cancer does not grow or spread.

Relacorilant (Lifyorli): A new drug that blocks the glucocorticoid receptor, preventing the stress hormone cortisol from helping cancer cells resist chemotherapy.

Therapeutic Goods Administration (TGA): The Australian government agency responsible for approving medicines and medical devices for use in Australia.