Generic Name: brexucabtagene autoleucel
Brand Name: TBC
Manufacturer: Gilead Sciences Canada Inc.
Therapeutic Area: Mantle cell lymphoma
Indications: For the treatment of adult patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have received treatment with a Bruton’s tyrosine kinase inhibitor (BTKi).
Manufacturer Requested Reimbursement Criteria1: For the treatment of adult patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have received treatment with a Bruton’s tyrosine kinase inhibitor (BTKi).
Submission Type: Initial
Tumour Type: Lymphoma
NOC Status at Filing: Pre NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule1: Schedule E
- 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 | November 20, 2020 |
| Call for patient/clinician input closed | January 22, 2021 |
| Clarification: - Patient input submission received from Lymphoma Canada | |
| Submission received | December 18, 2020 |
| Submission accepted | January 11, 2021 |
| Review initiated | January 12, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | March 30, 2021 |
| Deadline for sponsors comments | April 09, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | May 03, 2021 |
| Expert committee meeting (initial) | May 14, 2021 |
| Draft recommendation issued to sponsor | May 27, 2021 To May 31, 2021 |
| Draft recommendation posted for stakeholder feedback | - |