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Outline
What is the generic name?
VINCRISTINE SULFATE
What is the Trade Name for VINCRISTINE SULFATE?
Marqibo
What are the Indications for VINCRISTINE SULFATE?
- 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).
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References: https://open.fda.gov/
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