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MYL-1401H

Phase 3

Breast Neoplasms | Monoclonal antibody | Oncology |Viatris Inc.|Last Updated: Feb 14, 2022

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment193
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02467868Efficacy and Safety Study With MYL-1401H and NeulastaPHASE3 COMPLETED 193 — — Mar 1, 2015Feb 1, 2016Feb 14, 202236 Bulgaria, Georgia +4
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Study Endpoints
Primary Endpoints
Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) < 0.5 × 109/L
Cycle 1 of chemotherapy (approx 21 days)
Secondary Endpoints
The rate of febrile neutropenia (FN)
Week 24 (End of the study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MYL-1401HEXPERIMENTALMYL-1401H
NeulastaACTIVE_COMPARATORNeulasta
Interventions
NameTypeDescription
MYL-1401HBIOLOGICALDuring each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.
NeulastaBIOLOGICALDuring each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * Signed and dated written informed consent. * Patients ≥18 years. * Women of child-bearing potential must agree to use effective methods of birth control during the treatment period from the first dose of study drug until 6 months following the last dose of study drug. * Newly ...

Countries:BulgariaGeorgiaGermanyHungaryPolandUkraine
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