New Pill for Ovarian Cancer That No Longer Responds to Chemo

Lifyorli (relacorilant; Patient Information pronunciation lif-YOR-lee) is an oral glucocorticoid receptor antagonist. On the USPI it is given as soft gelatin capsules, taken with food, swallowed whole (do not crush, chew, dissolve, or split). It is labelled only in combination with nab-paclitaxel for the platinum-resistant ovarian / fallopian / primary peritoneal indication above — not as monotherapy on this label.

Distinct path — not this label (fact-only): Corcept has also pursued relacorilant for hypertension secondary to hypercortisolism / Cushing-related disease. Company and regulatory communications describe an FDA complete response letter (CRL) in December 2025 on that path. That CRL path is not the labelled commercial door described here. Today’s US labelled indication is platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with nab-paclitaxel. Do not treat Cushing / hypercortisolism resubmission timelines as this PROC label.

The FDA approved NDA 220641 on 25 March 2026 (Novel Drug Approvals for 2026 table row 9). This is a traditional / full NDA approval letter (not accelerated approval on the letter retrieved for this draft). Approval letter signed R. Angelo de Claro, MD, Office Director (Acting), Office of Oncologic Diseases (electronic signature ROMEO A DE CLARO). NDA received 11 July 2025. Applicant / manufactured for: Corcept Therapeutics Incorporated, Redwood City, CA 94065. The application was not referred to an FDA advisory committee. Dating period on the letter: 24 months from manufacture when stored at 20–25 °C. USPI / PPI versioning: USPI-220641-v01 03/2026 / PPI-220641-v01 03/2026. Reference ID 5769425. Pediatric studies under PREA were waived (impossible or highly impracticable for this oncology indication).

Where this is taking place

Commercial labelled door today: United States — FDA full approval for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens including bevacizumab, used with nab-paclitaxel. This is a gynecologic oncology clinic conversation with weekly infusion logistics, blood-count monitoring, and a labelled peri-infusion oral schedule — not a casual retail pickup and not a DIY import.

Outside the United States: As of this draft, no confirmed Health Canada Notice of Compliance, European Commission marketing authorisation, MHRA licence, TGA ARTG listing, Swissmedic authorisation, or PMDA/MHLW licence for Lifyorli / relacorilant. Company materials describe an EMA MAA submitted (October 2025) for platinum-resistant ovarian cancer — MAA under review ≠ EC marketing authorisation. Do not import on your own.

ROSELLA — NCT05257408 (USPI Study) — Phase 3, multicenter, open-label, active-controlled, randomized 1:1. Lead sponsor on ClinicalTrials.gov: Corcept Therapeutics. Collaborator: Gynecologic Oncology Group. CT.gov status: ACTIVE, NOT RECRUITING. Actual enrolment 381. Start 29 Jun 2022; actual primary completion 24 Mar 2025; estimated study completion March 2026. Study Director on the record: Sachin Pai, MD (Corcept Therapeutics). Countries with listed sites include the United States, Argentina, Australia, Belgium, Brazil, Canada, France, Hungary, Israel, Italy, Poland, South Korea, Spain, and the United Kingdom. Canadian sites on the record: Site 117 (Toronto, Ontario) and Site 273 (Montreal, Quebec) — facility names incomplete on the API record — trial geography, not a Health Canada licence. Expanded access: CT.gov record retrieved for this draft lists hasExpandedAccess: false — no expanded access listed on that record. Not a new-enrolment path for newly labelled commercial use — the pivotal efficacy population that supports the label is already enrolled; follow-up continues.

The practical door in the US is a gynecologic oncology clinician who can confirm platinum-resistant disease, prior-line history (including bevacizumab), arrange nab-paclitaxel 80 mg/m² on Days 1 / 8 / 15 of a 28-day cycle with Lifyorli 150 mg on the peri-infusion days, monitor blood counts, and watch for infection and adrenal-insufficiency symptoms — not treating NCT05257408 as open recruitment, and not treating an EMA filing as a foreign carton.

Approval matrix

Access by country

• United States: Ask a gynecologic oncology clinic about FDA-labelled Lifyorli. Labelled 25 March 2026 (traditional approval) for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens including bevacizumab, in combination with nab-paclitaxel. Recommended Lifyorli dose: 150 mg orally once on the day before, day of, and day after each nab-paclitaxel infusion until progression or unacceptable toxicity. Nab-paclitaxel with Lifyorli: 80 mg/m² IV on Days 1, 8, and 15 of each 28-day cycle (label notes this schedule differs from other nab-paclitaxel indications). Strengths: 25 mg and 100 mg capsules. Example packs: 150 mg blister NDC 76346-450-01 (one 100 mg + two 25 mg); also 76346-550-03, 76346-550-09; reduced 125 mg packs 76346-425-01, 76346-525-03, 76346-525-09. Prior authorisation and specialty-pharmacy / infusion-center logistics still apply. No list price or copay dollars in this article. Suspected adverse reactions: Corcept Therapeutics 1-855-844-3270 or FDA MedWatch 1-800-FDA-1088. Product information: www.LIFYORLI.com / 1-855-439-6754. Prescribing Information: FDA label PDF. This is US commercial labelled supply, not a DIY import.

• Canada: Lifyorli authorisation not confirmed. ROSELLA lists Toronto and Montreal research sites — trial ≠ Health Canada licence. Do not assume SAP, named-patient, or cross-border mail-order is available or appropriate. Ask the Canadian gynecologic oncology clinic what legal paths exist in Canada when a Lifyorli Canadian label does not yet exist.

• European Union / United Kingdom / Australia / other countries with trial sites: Regulator authorisation not confirmed in this draft. An EMA MAA under review (company claim) is not a licence. Trial participation is not a commercial Lifyorli label.

• If your regulator has not authorised it: do not import on your own. Ask the local oncology clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting — without treating a US blister pack as a foreign carton.

Who is eligible (from the US label)

This is an adult platinum-resistant epithelial ovarian / fallopian tube / primary peritoneal cancer conversation on the USPI — after 1–3 prior systemic regimens including bevacizumab — used with nab-paclitaxel, not a front-line labelled indication and not a paediatric ovarian label.

United States (USPI / Patient Information, revised / issued March 2026):

• Indication: Treatment of adult patients 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, in combination with nab-paclitaxel.
• Recommended dosage: Lifyorli 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. Nab-paclitaxel 80 mg/m² IV on Days 1, 8, and 15 of each 28-day cycle. Do not substitute other paclitaxel formulations. Interrupt or discontinue Lifyorli whenever nab-paclitaxel is interrupted or discontinued.
• Take with food. Swallow capsules whole.
• Missed dose: If missed by less than 12 hours, take the missed dose; if missed by 12 hours or more, skip — do not double. If vomiting after a dose, do not take an extra dose.
• Dose reductions: First Lifyorli reduction to 125 mg peri-infusion; permanently discontinue Lifyorli if unable to tolerate after one reduction. Nab-paclitaxel reductions per label Table 1 (first 60 mg/m² Days 1/8/15; second 60 mg/m² Days 1 and 15 only).
• Contraindication: Concurrent systemic glucocorticoid therapy for a lifesaving indication.
• Pregnancy / contraception: Can cause fetal harm. Verify pregnancy status before start when applicable. Females of reproductive potential: effective contraception during treatment and for 1 week after the last dose. Males with female partners of reproductive potential: effective contraception during treatment and for 1 week after the last dose.
• Lactation: Advise not to breastfeed.
• Hepatic impairment: Avoid use in patients with moderate or severe hepatic impairment.
• Pediatrics: Safety and effectiveness not established (PREA waived for this application).
• Trial context (ROSELLA): prior bevacizumab required; chronic or frequent glucocorticoid use excluded; control arm used nab-paclitaxel 100 mg/m² (labelled combination uses 80 mg/m² — do not collapse those numbers).

Not labelled on sources confirmed for this draft:

• Children / adolescents for this indication.
• EU, UK, Canadian, Japanese, Australian, or Swiss Lifyorli marketing authorisations (not confirmed here).
• Lifyorli monotherapy for PROC on this USPI.
• Using Lifyorli for hypercortisolism / Cushing under this PROC label (separate CRL path — not this commercial door).
• Treating ROSELLA follow-up as open commercial enrolment.

What the pivotal study showed (ROSELLA / USPI)

Use the USPI for a US prescription conversation. Journals and conference abstracts are supportive reading.

ROSELLA — NCT05257408:

• Multicenter, open-label, active-controlled, randomized 1:1; 381 adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer; up to three prior systemic lines; prior bevacizumab required; chronic/frequent glucocorticoids excluded.
• Arms: Lifyorli 150 mg peri-infusion + nab-paclitaxel 80 mg/m² Days 1/8/15 q28 (n=188) versus nab-paclitaxel 100 mg/m² Days 1/8/15 q28 (n=193).
• Major efficacy outcomes: PFS by BICR (RECIST 1.1) and OS.
• Median age 62 (26–86); 99.5% prior taxane; 61% prior PARP inhibitor; all prior bevacizumab.

USPI Table 7 (efficacy):

Trial-status honesty: ROSELLA supports the US full label. CT.gov remains ACTIVE, NOT RECRUITING because follow-up continues — that is not a door for new commercial starters outside labelled US distribution. No expanded access is listed on the CT.gov record retrieved for this draft.

How it is taken (US label — keep this exact)

Safety (what the label puts first)

Contraindication: Concurrent systemic glucocorticoid therapy for a lifesaving indication.

Neutropenia and severe infections: In ROSELLA, decreased neutrophil count occurred in 74% of patients on Lifyorli + nab-paclitaxel (30% Grade 3, 15% Grade 4); febrile neutropenia 3.7%. Median time to onset of neutropenia 15 days (range 8–329). Monitor CBC prior to each weekly treatment and as clinically indicated; withhold / reduce / discontinue per label. Consider concurrent adrenal insufficiency in serious infection.

Adrenal insufficiency: Relacorilant is a reversible GR antagonist and can cause adrenal insufficiency at any time; risk increases with stress (acute illness, infection, surgery). Serum cortisol does not accurately assess adrenal insufficiency on Lifyorli. Withhold Lifyorli and give glucocorticoid therapy if adrenal insufficiency is suspected; high-dose glucocorticoids may be needed. Educate patients on symptoms and when to call.

Exacerbation of conditions treated with glucocorticoids: Lifyorli makes systemic glucocorticoids less effective in patients who still need them for an ongoing indication.

Embryo-fetal toxicity: Can cause fetal harm. Contraception windows as above (1 week after last dose for females and for males with partners of reproductive potential).

Most common adverse reactions (>20%, including laboratory abnormalities): decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Selected Table 5 rates (Lifyorli + nab-paclitaxel, N=188, ≥10% all-grade examples): fatigue 54% (Grade 3/4 9%); nausea 44%; diarrhea 40%; rash 24%; decreased appetite 22%; edema 19%; stomatitis 19%.

Serious ARs: 35% (neutropenia 4%, pneumonia 3.2%, pleural effusion 3.2%, febrile neutropenia 2.1%, fatigue 2.1% among ≥2%). Fatal ARs 2.1% (septic shock, cardiac arrest, ischemic stroke, intestinal perforation — 0.5% each). Permanent discontinuation of the combination 9% (intestinal obstruction 2.6% among >2%). Lifyorli dosage interruptions 72%; Lifyorli dose reductions 7.4%; nab-paclitaxel dose reductions 48%.

Drug interactions (high level): Avoid strong CYP3A inducers with Lifyorli + nab-paclitaxel. Monitor for reduced effectiveness with CYP2C8 inducers and moderate CYP3A inducers. Monitor / modify for CYP2C8 inhibitors. Avoid coadministration with certain CYP3A substrates and certain CYP2C8 substrates unless otherwise recommended. Glucocorticoid effectiveness may be reduced.

Report suspected adverse reactions to Corcept Therapeutics 1-855-844-3270 or FDA MedWatch 1-800-FDA-1088.

No boxed warning on the USPI retrieved for this draft. That is not “no risk” — neutropenia / infections, adrenal insufficiency, glucocorticoid antagonism, and pregnancy are the main labelled safety story.

How to talk to a doctor

Bring the brand, the INN, the NDA / NCT numbers, and the US Prescribing Information if you are in a US clinic. Outside the US, bring honesty that a local Lifyorli label may not exist yet.

1. “I am an adult with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens, including bevacizumab. The FDA approved Lifyorli (relacorilant) with nab-paclitaxel on 25 March 2026. Is that labelled for me in this country?”
2. “The labelled Lifyorli dose is 150 mg by mouth on the day before, day of, and day after each nab-paclitaxel infusion, with food. Labelled nab-paclitaxel with Lifyorli is 80 mg/m² on Days 1 / 8 / 15 every 28 days — not the ROSELLA control-arm 100 mg/m². How will we schedule infusions and capsules?”
3. “ROSELLA (NCT05257408) showed median PFS 6.5 vs 5.5 months (HR 0.70) and median OS 16.0 vs 11.9 months (HR 0.65). What does that mean for my care plan?”
4. “Please cover neutropenia, infection precautions, G-CSF if needed, and how often CBC will be checked.”
5. “Please cover adrenal insufficiency symptoms and what to do if I get sick or need surgery. I understand cortisol blood tests may not work the usual way on this drug.”
6. “I am not asking about the separate hypercortisolism / Cushing CRL path — only this PROC label.”
7. “Please plan pregnancy testing and contraception during treatment and for 1 week after if I can become pregnant / if I have a partner who can. Advise on breastfeeding rules.”
8. “Please review my other medicines for CYP3A / CYP2C8 interactions and any glucocorticoid needs.”
9. “Is prior authorisation started? Who coordinates the blister packs (for example NDC 76346-450-01) and the nab-paclitaxel infusions?”
10. “Ex-US Lifyorli authorisations are not confirmed on the sources we are using (an EMA MAA under review is not a licence). I will not import a foreign carton.”

Research and regulatory team (from sources only — no invented contacts)

Names and roles as they appear on primary sources — not a clinic directory.

• Corcept Therapeutics Incorporated, Redwood City, CA 94065 — NDA 220641 applicant; USPI “Manufactured for”; AE line 1-855-844-3270; product info www.LIFYORLI.com / 1-855-439-6754.
• Corcept Therapeutics — ClinicalTrials.gov lead sponsor for NCT05257408.
• Gynecologic Oncology Group — ClinicalTrials.gov collaborator for NCT05257408.
• Sachin Pai, MD — Study Director, Corcept Therapeutics — named on the CT.gov record for ROSELLA (trial leadership, not a national referral desk).
• Dorothee Alatorre, PhD — Senior Director, Regulatory Affairs, Corcept — addressee on the NDA approval letter (corporate regulatory contact, not a treating clinic).
• R. Angelo de Claro, MD — Office Director (Acting), Office of Oncologic Diseases — signed the 25 March 2026 approval letter.
• Site-level hospital phone numbers are not listed here — ask your own gynecologic oncology clinician. CT.gov Canadian facilities are listed as Site 117 / Site 273 without complete facility names on the record retrieved for this draft.

Canada zoom: Lifyorli not confirmed

There is no retrieved Health Canada Notice of Compliance or DIN for Lifyorli / relacorilant on the sources used for this draft. US FDA approval does not create a Canadian Product Monograph. ROSELLA lists Toronto and Montreal research sites — that is trial geography, not a licence. Do not treat cross-border mail-order of a US blister pack as the care plan. Ask a Canadian gynecologic oncology clinician what legal options exist while waiting for any future Canadian Lifyorli decision.

Bottom line

Lifyorli (relacorilant) is an FDA-approved oral glucocorticoid receptor antagonist — labelled 25 March 2026 under traditional / full approval (NDA 220641) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1–3 prior systemic regimens including bevacizumab. Dose: 150 mg by mouth on the day before, day of, and day after each nab-paclitaxel infusion (with food); nab-paclitaxel 80 mg/m² IV Days 1 / 8 / 15 every 28 days. ROSELLA (NCT05257408) showed median PFS 6.5 vs 5.5 months (HR 0.70) and median OS 16.0 vs 11.9 months (HR 0.65). Watch neutropenia / infections, adrenal insufficiency, glucocorticoid antagonism, and pregnancy. US labelled. Other major regulators not confirmed. An EMA MAA under review is not a foreign licence. A separate hypercortisolism / Cushing CRL path is not this PROC carton. The door is a gynecologic oncology clinic writing the US combination label — pivotal follow-up is not a new commercial enrolment path. Authorized is not funded.

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Primary sources

1. FDA Novel Drug Approvals for 2026 — Lifyorli / relacorilant, approval date 3/25/2026, row 9 — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
2. FDA oncology approval notice — FDA approves relacorilant with nab-paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-relacorilant-nab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or
3. FDA Prescribing Information PDF, NDA 220641, Reference ID 5769425, USPI-220641-v01 03/2026 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220641Orig1s000lbl.pdf
4. FDA NDA approval letter, NDA 220641, signed R. Angelo de Claro, MD, 25 March 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220641Orig1s000ltr.pdf
5. ClinicalTrials.gov NCT05257408 — ROSELLA — https://clinicaltrials.gov/study/NCT05257408
6. Product / patient information contact on label — www.LIFYORLI.com / 1-855-439-6754 (labelled contact, not a prescribing desk)