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Lurbinectedin

Generic Name
Lurbinectedin
Brand Names
Zepzelca, 赞必佳
Drug Type
Small Molecule
Chemical Formula
C41H44N4O10S
CAS Number
497871-47-3
Unique Ingredient Identifier
2CN60TN6ZS

Overview

Lurbinectedin is a DNA alkylating agent that has been investigated in the treatment of a variety of cancers, including mesothelioma, chronic lymphocytic leukemia (CLL), breast cancer, and small-cell lung cancer (SCLC). It is a derivative of the marine-derived agent ecteinascidin (trabectedin), an anticancer agent found in extracts of the tunicate Ecteinascidia turbinata, with the primary difference being the substitution of the tetrahydroisoquinoline with a tetrahydro β‐carboline that results in increased antitumour activity of lurbinectedin as compared to its predecessor. On June 15, 2020, the FDA granted accelerated approval and orphan drug designation to lurbinectedin for the treatment of adult patients with metastatic SCLC who have experienced disease progression despite therapy with platinum-based agents. This accelerated approval is based on the rate and duration of therapeutic response observed in ongoing clinical trials and is contingent on the verification of these results in confirmatory trials.

Background

Lurbinectedin is a DNA alkylating agent that has been investigated in the treatment of a variety of cancers, including mesothelioma, chronic lymphocytic leukemia (CLL), breast cancer, and small-cell lung cancer (SCLC). It is a derivative of the marine-derived agent ecteinascidin (trabectedin), an anticancer agent found in extracts of the tunicate Ecteinascidia turbinata, with the primary difference being the substitution of the tetrahydroisoquinoline with a tetrahydro β‐carboline that results in increased antitumour activity of lurbinectedin as compared to its predecessor. On June 15, 2020, the FDA granted accelerated approval and orphan drug designation to lurbinectedin for the treatment of adult patients with metastatic SCLC who have experienced disease progression despite therapy with platinum-based agents. This accelerated approval is based on the rate and duration of therapeutic response observed in ongoing clinical trials and is contingent on the verification of these results in confirmatory trials.

Indication

Lurbinectedin is indicated for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

Associated Conditions

  • Metastatic Lung Small Cell Carcinoma

FDA Approved Products

ZEPZELCA
Manufacturer:Jazz Pharmaceuticals, Inc.
Route:INTRAVENOUS
Strength:.5 mg in 1 mL
Approved: 2020/06/15
NDC:68727-712

Singapore Approved Products

ZEPZELCA POWDER FOR SOLUTION FOR INFUSION 4MG/VIAL
Manufacturer:GP–Pharm, S.A., Baxter Oncology GmbH
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:4.0 mg/vial
Online:Yes
Approved: 2021/09/21
Approval:SIN16327P

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