Generic Name: dinutuximab
Brand Name: Unituxin
Manufacturer: United Therapeutics Corp.
Therapeutic Area: Neuroblastoma
Indications: Forthe treatment of high-risk neuroblastoma patients in their first relapse ordetermination of refractory disease, in combination with irinotecan,temozolomide, and granulocyte macrophage colony-stimulating factor.
Manufacturer Requested Reimbursement Criteria1: For the treatment of high-risk neuroblastoma patients in their first relapse or determination of refractory disease, in combination with irinotecan, temozolomide, and granulocyte macrophage colony-stimulating factor.
Submission Type: Initial
Tumour Type: Neurological
Project Status: Active
Companion Diagnostics: No
Fee Schedule1: Schedule A
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient/clinician input open | October 22, 2020 |
| Call for patient/clinician input closed | December 10, 2020 |
| Clarification:
- Patient input submission received from Neuroblastoma Canada, the Canadian Organization for Rare Disorders, and Ontario Parents Advocating for Children with Cancer |
|
| Submission received | November 23, 2020 |
| Submission accepted | December 16, 2020 |
| Clarification:
- Submission was not accepted for review on 7 Dec 20 |
|
| Review initiated | December 17, 2020 |
| Draft CADTH review report(s) provided to sponsor for comment | March 10, 2021 |
| Deadline for sponsors comments | March 19, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | May 03, 2021 |
| Expert committee meeting (initial) | May 13, 2021 |
| Draft recommendation issued to sponsor | May 26, 2021 To May 28, 2021 |
| Draft recommendation posted for stakeholder feedback | - |