Lurbinectedin
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | DRUG-LURBINECTEDIN |
|---|---|
| Type | Médicament |
| Alias | ZépzelcaЛурбінектедин |
| État | reviewed 2026-04-29 | pending_clinical_signoff |
| Maladies | DIS-SCLC |
| Sources | SRC-CIVIC SRC-ESMO-SCLC-2021 SRC-NCCN-SCLC-2025 |
Faits sur les drogues
| Catégorie | Selective RNA polymerase II inhibitor (alkylating-like trabectedin analogue) |
|---|---|
| Mécanisme | Synthetic tetrahydroisoquinoline alkaloid that binds the minor groove of DNA and stalls RNA polymerase II elongation, triggering RNAPII ubiquitination, double-strand breaks, and apoptosis selectively in transcription-addicted tumor cells. Also depletes tumor-associated macrophages. ATLANTIS (Phase III lurbinectedin + doxorubicin vs topotecan/CAV in 2L SCLC) failed its OS primary endpoint, but the pivotal single-arm Phase II Basket Study (NCT02454972, lurbinectedin monotherapy 3.2 mg/m² q21d) showed ORR 35% in 2L SCLC (CTFI ≥90 d ORR 45%; CTFI <90 d ORR 22%), supporting accelerated FDA approval Jun 2020. |
| Dose typique | 3.2 mg/m² IV over 60 minutes once every 21 days (Q21D), with prophylactic 5-HT3 antiemetics + dexamethasone 8 mg PO/IV ≥30 min pre-infusion. Dose reductions to 2.6 mg/m² and 2.0 mg/m² for grade ≥3 hematologic or hepatic toxicity. Discontinue if febrile neutropenia recurs at 2.0 mg/m² or for any unresolved grade 4 toxicity. |
| Ukraine enregistrée | Faux |
| NSZU remboursé | Faux |
| Ukraine vérifiée pour la dernière fois | 2026-04-29 |
Notes
FDA-accelerated approval (Jun 2020) for metastatic SCLC progressing on or after platinum-containing chemotherapy, based on single-arm Basket Study (NCT02454972) ORR 35%, mDOR 5.3 months. The confirmatory ATLANTIS Phase III (lurbinectedin + doxorubicin vs topotecan/CAV) failed its OS primary endpoint (mOS 8.6 vs 7.6 mo, HR 0.97, NS), prompting EMA refusal (2022) but did not trigger US withdrawal — monotherapy benefit-risk in platinum-sensitive 2L SCLC remained acceptable. NCCN-SCLC 2025 lists lurbinectedin (category 2A) for relapsed SCLC alongside topotecan; preferred when CTFI ≥90 days. Bibliographic/regulatory records are available for SRC-ATLANTIS-PAZ-ARES-2023, SRC-LURBINECTEDIN-BASKET, and SRC-FDA-ZEPZELCA; clinical claim mapping remains subject to qualified clinical review. Active investigations: lurbinectedin + atezolizumab (IMforte 1L maintenance, positive Phase III readout 2025).
Utilisé par
Protocole thérapeutique
REG-LURBINECTEDIN-SCLC-RR- Lurbinectedin en monothérapie (SCLC, rechute/réfraction, ≥2L)