Initial US Approval:
2026
Key Clinical Studies:
ROSELLA (NCT05257408)
Drug Class/Description:
Glucocorticoid receptor antagonist
Indications and Usage:
LIFYORLI is a glucocorticoid receptor antagonist indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
Dosage and Administration:
The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion.
Dosage Forms and Strengths:
Capsules: 25 mg, 100 mg
Contraindications:
Concurrent systemic glucocorticoid therapy for a lifesaving indication.
Warnings and Precautions:
- Neutropenia and Severe Infections: Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Withhold, reduce the dose, or permanently discontinue LIFYORLI based on severity.
- Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency.
- Exacerbation of Conditions Treated with Glucocorticoids: LIFYORLI makes systemic glucocorticoids less effective in patients who have an ongoing requirement for systemic glucocorticoids.
- Embryo-Fetal Toxicity: LIFYORLI can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception.
Adverse Reactions:
Most common adverse reactions (incidence > 20%), including laboratory abnormalities, that occurred in patients treated with LIFYORLI in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.
Drug Interactions:
- Strong CYP3A Inducers: Avoid coadministration with LIFYORLI in combination with nab-paclitaxel.
- CYP2C8 Inducers and Moderate CYP3A Inducers: Monitor for reduced effectiveness for LIFYORLI in combination with nabpaclitaxel.
- CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended.
- CYP3A Substrates: Avoid coadministration unless otherwise recommended.
- Certain CYP2C8 Substrates: Avoid coadministration unless otherwise recommended.
Use in Specific Populations:
- Lactation: Advise not to breastfeed.
- Hepatic Impairment: Avoid use in patients with moderate or severe hepatic impairment.
Adapted From:
https://corcept.com/wp-content/uploads/Lifyorli_PI.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
