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LURBINECTEDIN
CAS NO.: 497871-47-3
Chemical Formula: C41H44N4O10S
Molecular Weight: 784.9000
DMF&GMP status: Please contact us for more details.
Description:
Lurbinectedin is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death.

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.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
LURBINECTEDINPOWDER;INTRAVENOUS4MG/VIALZEPZELCAJAZZ PHARMACEUTICALS IRELAND LTD
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
776361512/13/2024DSDPU-2836
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 06/15/2025
ODE-304 06/15/2027