Lurbinectedin

What lurbinectedin is and how it works

Lurbinectedin (brand name Zepzelca) is a cancer medicine given by intravenous infusion in a hospital or cancer treatment centre, used to treat small cell lung cancer (SCLC), an aggressive form of lung cancer. It works by interfering with cancer cell DNA and the transcription processes cancer cells rely on to grow. (1) (2)

This is a chemotherapy-type medicine used specifically for small cell lung cancer, either after your cancer has progressed following platinum-based chemotherapy, or as ongoing maintenance treatment combined with another cancer medicine (atezolizumab) if your cancer has not progressed after initial treatment. It requires regular blood tests and close monitoring by your cancer care team because it can seriously affect your blood counts and liver.

Mechanism of action: how lurbinectedin works

Lurbinectedin is a selective inhibitor of oncogenic transcription that binds DNA and inhibits active transcription, inducing DNA breaks and apoptosis (programmed cell death) in tumour cells; it also affects the tumour microenvironment. (1)

What lurbinectedin is used for

Before taking lurbinectedin

Do not take / not appropriate for

• Do not receive lurbinectedin if you have ever had a hypersensitivity reaction to lurbinectedin or to any of the other ingredients in the product. This is an absolute contraindication in the EU product information; the US prescribing information lists no contraindications. (European Union) (1)
• Do not breastfeed while you are being treated with lurbinectedin. Breast-feeding is listed as an absolute contraindication in the EU product information, and the US prescribing information advises women not to breastfeed during treatment and for 2 weeks after the final dose. (all countries) (1)
• A cycle of lurbinectedin should not be given if your neutrophil count is below 1.5 x 10⁹/L or your platelet count is below 100 x 10⁹/L. This is a treatment-delay rule rather than a permanent contraindication — treatment is withheld until your blood counts recover. (European Union)
• Lurbinectedin should not be given to people with severe kidney impairment (creatinine clearance under 30 mL/min) or end-stage kidney disease, because it has not been studied in enough of these patients to estimate the risk. (European Union)
• Lurbinectedin is not recommended if your liver enzymes (AST or ALT) are more than 3 times the upper limit of normal, and use in severe liver impairment should be avoided unless the benefit outweighs the risk. Discuss this with your oncology team rather than stopping treatment yourself. (European Union)

Tell your clinician about

• Any history of low blood counts, bleeding problems, or infections.
• Any liver problems or history of liver disease.
• Whether you are, could be, or are planning to become pregnant -- lurbinectedin can cause fetal harm.
• Whether you are breastfeeding.
• All other medicines you take, since some may affect how lurbinectedin is processed by your body.
• Your age, since older adults (65 and over) had a higher rate of serious side effects in clinical trials.

How to take lurbinectedin

• Lurbinectedin is given only by a healthcare professional, as an intravenous infusion over 60 minutes, typically every 21 days (3 weeks).
• Administration through a central venous line is recommended to reduce the risk of the medicine leaking into surrounding tissue (extravasation), which can cause tissue damage.
• Your care team will check your blood counts before every dose and will not give a dose if your counts are too low -- your treatment schedule may be delayed or your dose adjusted based on these results.
• Your liver function will be tested before starting treatment and periodically during treatment.

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Not applicable in the usual sense -- lurbinectedin is scheduled and administered entirely by your cancer care team based on your blood test results and overall condition; if an appointment needs to be rescheduled, your treatment centre will advise you.

Overdose

Because this medicine is given only in a monitored clinical setting by trained staff, an overdose would be managed directly by your treatment team. Report any severe or worsening symptoms -- such as fever, unusual bleeding or bruising, severe fatigue, or yellowing of the skin or eyes -- to your care team immediately. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Serious warnings

Interactions

• Tell your care team about all other medicines you take, as some may affect how your body processes lurbinectedin or add to its effects on blood counts or the liver. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Monitoring

Before starting

• Full blood count (must meet minimum neutrophil and platelet thresholds before starting)
• Liver function tests
• Pregnancy test where applicable

During treatment

• Full blood count checked before every dose (approximately every 21 days).
• Liver function tests monitored periodically throughout treatment.
• Monitoring for signs of infection, bleeding, and infusion-site reactions.

Storage

Stored and prepared by pharmacy/oncology staff according to the product's labelling; not a medicine kept or handled by patients at home.

Frequently asked questions

References

1. ZEPZELCA (lurbinectedin) for injection -- prescribing informationU.S. Food and Drug Administration / DailyMed (NIH) · United States · accessed 2026-07-31 · source 1
2. Zepzelca (lurbinectedin) -- European Public Assessment Report (EPAR)European Medicines Agency (EMA) · European Union · accessed 2026-07-31 · source 2
3. Zepzelca (lurbinectedin) -- Innovation Passport (Innovative Medicine Designation) granted 2022; no MHRA marketing authorisation foundUK Medicines and Healthcare products Regulatory Agency (MHRA) -- status confirmed via manufacturer/press disclosure, cross-checked against absence of any emc SmPC listing · United Kingdom · accessed 2026-07-31 · source 3
4. Zepzelca (lurbinectedin) -- Summary Basis of Decision and Product MonographHealth Canada · Canada · accessed 2026-07-31 · source 4
5. ZEPZELCA lurbinectedin 4 mg powder for solution for infusion -- ARTG entry 335536Therapeutic Goods Administration (TGA), Australia -- Australian Register of Therapeutic Goods (ARTG) · Australia · accessed 2026-07-31 · source 5
6. Lurbinectedin -- classified as Prescription Medicine in NZ Gazette notices (2023-2024); no confirmed marketed product foundMedsafe (New Zealand Medicines and Medical Devices Safety Authority) · New Zealand · accessed 2026-07-31 · source 6

Brand names by country

Single-ingredient lurbinectedin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries