pertuzumab


( Last Updated : October 21, 2021)
Generic Name:
pertuzumab
Project Status:
Active
Therapeutic Area:
Early stage breast cancer
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Perjeta
Project Line:
Reimbursement Review
Project Number:
PC0241-000
Tumour Type:
Breast
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
Pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive). Patients should receive neoadjuvant treatment with pertuzumab in combination with trastuzumab and chemotherapy for three to six cycles depending on the regimen chosen. Patients who start pertuzumab in combination with trastuzumab and chemotherapy in the neoadjuvant setting and do not have residual disease following surgery should continue to receive adjuvant trastuzumab to complete one year of HER2-directed therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Perjeta in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either 2 cm in diameter or node positive).
  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 March 16, 2021
Call for patient/clinician input closed May 07, 2021
Clarification:

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

Submission received April 14, 2021
Submission accepted April 28, 2021
Review initiated April 29, 2021
Draft CADTH review report(s) provided to sponsor for comment July 21, 2021
Deadline for sponsors comments July 30, 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 21, 2021
Draft recommendation posted for stakeholder feedback October 1, 2021
End of feedback period October 18, 2021
Clarification:

- Reconsideration: major revisions requested by sponsor