Drug · Small Molecule
Lurbinectedin
CI-DRUG-00000749Explore in graph →CHEMBL4297516 Approved
Regulatory
Approvals (6)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2025-10-02 (see label) | approved | Oct 2, 2025 | openfda |
| US FDA | Lung Small Cell Carcinoma | in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. | approved | Jun 15, 2020 | openfda |
| US FDA | Lung Small Cell Carcinoma | For the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. | approved | Jun 15, 2020 | openfda |
| US FDA | — | This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 29 | 19 | 10 | 56 | 6 | CA, EU, US | Jun 15, 2020 | 2009-03 |
| Malignant Lung Neoplasm | Approved | Phase 3 | 20 | 13 | 8 | 27 | 3 | EU, US | Jun 15, 2020 | Sep 11, 2013 |
| Malignant Ovarian Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 2 | 0 | — | — | 2015-05 |
| Malignant Breast Neoplasm | Phase2 | Phase 2 | 0 | 0 | 0 | 2 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (59)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT02421588 | Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients(CORAIL) | completed | Phase 3 | 442 | PharmaMarINDUSTRY | 1 | Apr 3, 2020 | clinicaltrials |
| NCT01970540 | Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors | completed |