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Lurbinectedin - PharmaMar

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Drug Profile

Lurbinectedin - PharmaMar

Alternative Names: JZP-712; Lurbinectedina - PharmaMar; LY-01017; PM-01183; PM-1183; Tryptamicidin; Zepsyre; ZEPZELCA; Zepzelca

Latest Information Update: 16 Jun 2025

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At a glance

  • Originator PharmaMar
  • Developer ADIUM PHARMA; Immedica; Jazz Pharmaceuticals plc; Luye Pharma Group; PharmaMar; Roche; Specialised Therapeutics Asia; Swiss Group for Clinical Cancer Research
  • Class 3-ring heterocyclic compounds; Acetates; Alkaloids; Antineoplastics; Carbolines; Dioxolanes; Indoles; Small molecules; Spiro compounds; Tetrahydroisoquinolines
  • Mechanism of Action Alkylating agents; DNA damage stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Ovarian cancer; Malignant-mesothelioma; Soft tissue sarcoma; Small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Small cell lung cancer
  • Phase III Ovarian cancer
  • Phase II/III Leiomyosarcoma
  • Phase II Breast cancer; Malignant-mesothelioma; Non-small cell lung cancer; Pancreatic cancer; Sarcoma; Solid tumours
  • Phase I/II Ewing's sarcoma; Soft tissue sarcoma

Most Recent Events

  • 10 Jun 2025 FDA assigns PDUFA action date of 07/10/2025 for lurbinectedin for Small cell lung cancer (First-line therapy, Late-stage disease, Chemotherapy-induced) (IV)
  • 10 Jun 2025 Lurbinectedin receives priority review status for Small cell lung cancer (First-line therapy, Late-stage disease, Chemotherapy-induced) in USA (IV)
  • 10 Jun 2025 US FDA accepts sNDA for lurbinectedin for Small cell lung cancer (First-line therapy, Late-stage disease, Chemotherapy-induced) (IV) for review

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