Unituxin for Neuroblastoma – Details


( Last Updated : April 10, 2019)
Generic Name:
Dinutuximab
Project Status:
Complete
Therapeutic Area:
Neuroblastoma
Manufacturer:
United Therapeutics Corp.
Brand Name:
Unituxin
Project Line:
Reimbursement Review
Project Number:
PC0154-000
NOC Status at Filing:
Pre NOC
NOC Date:

Details


Strength:
3.5 mg / mL
Tumour Type:
Neurological
Indications:
Neuroblastoma
Funding Request:
To be used in combination with GM-CSF, IL-2 and Retinoic acid (RA) for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multi-agent, multimodal therapy
Pre Noc Submission:
Yes
Sponsor:
United Therapeutics Corp.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.