Application Nr Approved Date Route Status External Links
NDA213702 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zepzelca Is Indicated For The Treatment Of Adult Patients With Metastatic Small Cell Lung Cancer (Sclc) With Disease Progression On Or After Platinum-Based Chemotherapy. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate And Duration Of Response [See Clinical Studies (14) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S). Zepzelca Is An Alkylating Drug Indicated For The Treatment Of Adult Patients With Metastatic Small Cell Lung Cancer (Sclc) With Disease Progression On Or After Platinum-Based Chemotherapy. ( 1 ) 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). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Lurbinectedin

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