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tucatinib

Last Updated: April 26, 2021
Result type: Reports
Project Number: PC0243-000
Product Line: Reimbursement Review

Generic Name: tucatinib

Brand Name: Tukysa

Manufacturer: Seagen Canada Inc.

Therapeutic Area: Advanced or Metastatic Breast Cancer

Indications: ​Tucatinib is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.

Manufacturer Requested Reimbursement Criteria1: In combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.

Submission Type: Initial

Tumour Type: Breast

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule1: Schedule A

  1. 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 February 26, 2021
Clarification:

- Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer

Call for patient/clinician input closed April 23, 2021
Submission received March 26, 2021
Submission accepted April 12, 2021
Review initiated April 13, 2021
Draft CADTH review report(s) provided to sponsor for comment June 25, 2021
Deadline for sponsors comments July 07, 2021
CADTH responses on draft review report(s) provided to sponsor August 26, 2021
Expert committee meeting (initial) September 08, 2021
Draft recommendation issued to sponsor September 20, 2021
To
September 22, 2021
Draft recommendation posted for stakeholder feedback -