Overview
Ancestim is a non-glycosylated recombinant methionyl human stem cell factor. It is a 166 amino acid protein produced by E. coli with an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine. Ancestim was developed by Amgen and sold to Biovitrium in December 2008. It was submitted to the FDA under the status of recommendation for approval with a 10 to 1 votes. It was also approved by Health Canada in 1999 but it is currently under the status of canceled post-market.
Indication
Ancestim, in combination with filgrastim, is indicated for the setting of autologous peripheral blood progenitor cell transplantation in patients at risk of poor peripheral blood progenitor cell mobilisation. The use of ancestim with filgrastim will generate a sustained increase in the number of peripheral blood progenitor cells capable of engraftment. It is used for mobilization of progenitor cells from the bone marrow to the peripheral blood with or withouth mobilizing chemotherapy. The harvested progenitor cells can be used for transplant following myelosuppressive or myeloablative therapies.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
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1999/11/04 | Phase 2 | Completed |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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