Lurbinectedin
A marine-derived chemotherapy that jams cancer's gene-reading machinery, approved for relapsed small-cell lung cancer and, since 2025, as first-line maintenance with atezolizumab.
Accelerated approval June 2020 for metastatic SCLC after platinum (ORR 35%, DOR 5.3 months, basket phase 2). ATLANTIS (with doxorubicin) missed OS; IMforte (with atezolizumab as first-line maintenance) improved OS and PFS, leading to full approval on 2 October 2025. Also studied in the LAGOON second-line trial. Jazz Pharmaceuticals (US) and PharmaMar.
1.Binds guanine in the DNA minor groove at active promoters
- Route
- Intravenous
- Schedule
- 3.2 mg/m² over 60 minutes every 21 days (monotherapy); with atezolizumab 1200 mg in maintenance
- Dose modifications
- Delay and reduce for grade 3-4 neutropenia or hepatotoxicity
- Monitoring
- Blood counts and liver enzymes before each cycle
Source: www.accessdata.fda.gov/drugsatfda_docs/label/2025/213702s004lbl.pdf. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- JazzCares
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- Licensed in the US and EU but no UK marketing authorisation confirmed; NICE position not yet researched.
- NHS England
- Not routinely funded
Sources: NICE search: lurbinectedin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 15 Jun 2020ApprovalUS
Accelerated approval, second-line SCLC
- 2 Oct 2025ApprovalUS
Full approval with atezolizumab as first-line maintenance (IMforte) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Metastatic SCLC after platinum chemotherapy (accelerated) |
| US | 2025 | First-line maintenance with atezolizumab in ES-SCLC (full approval) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia | 71% | 46% |
| Fatigue | 77% | — |
| Nausea | 37% | — |
| Transaminase increase | 66% | — |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Lurbinectedin" OR ABSTRACT:"Lurbinectedin" OR TITLE:"Zepzelca" OR ABSTRACT:"Zepzelca" OR TITLE:"PM01183" OR ABSTRACT:"PM01183") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Lurbinectedin, not a curated reading list.
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