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Erwinase

Phase 1

Acute Lymphoblastic Leukemia | Small molecule | Oncology |Jazz Pharmaceuticals plc|Last Updated: Apr 26, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment87
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00693602Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins LymphomaPHASE1 COMPLETED 87Jun 1, 2006Dec 1, 2011Apr 26, 20171 United States
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Study Endpoints
Primary Endpoints
To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase
June 2009
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
ErwinaseDRUGChemotherapy
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma receiving ALL-type therapy who have developed hypersensitivity or intolerance to E. coli L-asparaginase or PEG-L-asparaginase or both. * Informed consent explained to and signed by parent/legal gua...

Countries:United States
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