Marqibo

Product manufactured by Acrotech Biopharma Llc

Application Nr Approved Date Route Status External Links
NDA202497 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Marqibo Is A Vinca Alkaloid Indicated For The Treatment Of Adult Patients With Philadelphia Chromosome-Negative (Ph-) Acute Lymphoblastic Leukemia (All) In Second Or Greater Relapse Or Whose Disease Has Progressed Following Two Or More Anti-Leukemia Therapies. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S).( 1.1 ). 1.1 Acute Lymphoblastic Leukemia Marqibo ® Is Indicated For The Treatment Of Adult Patients With Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (All) In Second Or Greater Relapse Or Whose Disease Has Progressed Following Two Or More Anti Leukemia Therapies. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate [See Clinical Studies ( 14 )]. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Vincristine Sulfate VINCRISTINE SULFATE ZINC85432549

Comments