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Mylotarg

Phase 2

Acute Myelogenous Leukemia | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 18, 2006

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00044733Study Evaluating Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia After Stem Cell TransplantPHASE2 COMPLETED 38Mar 1, 2000Sep 1, 2004May 18, 200613 United States
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Study Design & Arms
MaskingNONE
Interventions
NameTypeDescription
Mylotarg (gemtuzumab ozogamicin) InjectionDRUG -
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Eligibility Criteria
Age Range0 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria * Patients with CD33+ AML who have experienced relapse after autologous or allogeneic HSCT. Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33 positive, based on local laboratory criteria (Patients with history of MDS pretransplant...

Countries:United States
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