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Faslodex for Locally Advanced or Metastatic Breast Cancer – Details

Project Number PC0110-000
Brand Name Faslodex
Generic Name Fulvestrant
Strength 50 mg/mL
Tumour Type Breast
Indication Locally Advanced or Metastatic Breast Cancer
Funding Request For hormonal treatment of non-visceral locally advanced or metastatic HER2- breast cancer in postmenopausal women, regardless of age, who have not been previously treated with endocrine therapy
Review Status Complete
Pre Noc Submission Yes
NOC Date November 8, 2017
Manufacturer AstraZeneca Canada Inc.
Sponsor AstraZeneca Canada Inc.
Submission Date July 17, 2017
Submission Deemed Complete July 24, 2017
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ July 31, 2017
Check-point meeting September 18, 2017
pERC Meeting November 16, 2017
Initial Recommendation Issued November 30, 2017
Feedback Deadline ‡ December 14, 2017
pERC Reconsideration Meeting January 18, 2018
Final Recommendation Issued February 1, 2018
Notification to Implement Issued February 16, 2018
Therapeutic Area Locally advanced or metastatic breast cancer
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.