Last Updated : August 20, 2013
Details
FilesGeneric Name:
Pertuzumab
Project Status:
Complete
Therapeutic Area:
Metastatic Breast Cancer
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Perjeta Herceptin Combo Pack
Project Line:
Reimbursement Review
Project Number:
PC0018-000
Strength:
420 mg/vial
Tumour Type:
Breast
Indications:
Metastatic Breast Cancer
Funding Request:
In combination with trastuzumab and a taxane for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
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.
Last Updated : August 20, 2013