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Synonyms: PM 01183 | PM-01183 | PM01183 | Zepzelca®
lurbinectedin is an approved drug (FDA (2020))
Compound class: Synthetic organic
Comment: Lurbinectedin (PM01183) is an investigational anti-tumour agent  with potential activity against a wide range of tumours. Structurally it is a synthetic tetrahydroisoquinoline that is related to the marine ecteinascidins (e.g. trabectedin). Like trabectedin, lurbinectedin binds to the minor groove of DNA. Stable lurbinectedin-DNA adducts induce DNA double- and single-strand breaks which cause cell cycle arrest and ultimately, apoptotic cell death.
|No information available.|
|Summary of Clinical Use|
|First-in-human results of lurbinectedin in patients with advanced solid tumours were reported in 2014 , and since then it has progressed to Phase 3 evaluations. Click here to link to ClinicalTrials.gov's full list of lurbinectedin/PM01183 studies.
In the EU lurbinectedin has orphan drug authorisation for ovarian cancer (granted in 2012) and small cell lung cancer (SCLC, 2019).
A new drug application (NDA) was submitted to the FDA in late 2019, and accelerated approval/priority review for use as a second-line therapy in patients with SCLC who have progressed after prior platinum-containing therapy was authorised in February 2020. This converted to full FDA approval for this SCLC indication in June 2020.
|Clinical Trial ID||Title||Type||Source||Comment||References|
|NCT02421588||Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients||Phase 3 Interventional||PharmaMar|
|NCT00877474||Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM01183 in Patients With Advanced Solid Tumors||Phase 1 Interventional||PharmaMar||1|
|NCT02566993||Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin (DOX) Versus Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR) (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer||Phase 3 Interventional||PharmaMar||2|