CDA | Evidence Driven
CDA | Evidence Driven

blinatumomab

Details

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Generic Name:
blinatumomab
Project Status:
Active
Therapeutic Area:
Acute lymphoblastic leukemia, pediatrics
Manufacturer:
N/A
Call for patient/clinician input open:
Brand Name:
N/A
Project Line:
Reimbursement Review
Project Number:
PX0367-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Submission Type:
Non-sponsored Submission
Fee Schedule:
Pending
Indications:
Indicated for the pediatric patients with Philadelphia chromosome negative relapsed/refractory B precursor acute lymphoblastic leukemia (ALL) who are in first relapse.
Key Milestones2
Submission receivedJune 19, 2024
Review initiatedJune 20, 2024
Expert committee meeting (initial)November 21, 2024
Draft recommendation posted for stakeholder feedbackDecember 12, 2024
End of feedback periodJanuary 03, 2025

Files

Draft Recommendation View PDF
Draft Report View PDF
Draft Supplemental Materials View PDF
Responses to the Questions From the Drug Programs View PDF
Proposed Scope View PDF

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Last Updated : December 12, 2024