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Faslodex for Locally Advanced or Metastatic Breast Cancer – Details

Project Number pCODR 10110
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 Under Review
Pre Noc Submission Yes
NOC Date November 8, 2017
Manufacturer AstraZeneca Canada Inc.
Submitter AstraZeneca Canada Inc.
Submission Date July 17, 2017
Submission Deemed Complete July 24, 2017
Submission Type New Drug
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ July 31, 2017
Check-point meeting September 18, 2017
pERC Meeting November 16, 2017
Initial Recommendation Issued (target date) November 30, 2017
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ 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.