OnCo
drugsProductApproved2020🇦🇺

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.

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Lurbinectedin · 2D coordinates (no PubChem conformer)
PubChem
Mechanism, step by step
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1.Binds guanine in the DNA minor groove at active promoters

Modality
Cytotoxic (transcription inhibitor)
Mechanism
Binds the DNA minor groove at CG-rich promoters, stalls RNA polymerase II and triggers its degradation; also depletes tumour-associated macrophages.
Brand / code
Zepzelca · PM01183
Dosing & schedule
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

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.

Not appraisedSearch NICE
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.

Regulatory

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  1. 15 Jun 2020ApprovalUS

    Accelerated approval, second-line SCLC

  2. 2 Oct 2025ApprovalUS

    Full approval with atezolizumab as first-line maintenance (IMforte) source

Approvals

RegionYearIndication
US2020Metastatic SCLC after platinum chemotherapy (accelerated)
US2025First-line maintenance with atezolizumab in ES-SCLC (full approval)

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
50 studies17 recruiting38 Phase 212 Phase 3
Search “Lurbinectedin” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Lurbinectedin
intervention: Lurbinectedin
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend45 papers in the last 12 months+29% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query 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.

Connected

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