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Afinitor for Advanced Breast - Details

Project Number PC0014-000
Brand Name Afinitor
Generic Name Everolimus
Strength 2.5 mg, 5mg and 10 mg
Tumour Type Breast
Indication Advanced Breast Cancer
Funding Request For treatment of post menopausal women with hormone receptor-positive advanced breast cancer in combination with exemestane, after progression or recurrence (failure) on NSAI therapy.
Review Status Complete
Pre Noc Submission Yes
NOC Date January 10, 2013
Manufacturer Novartis Pharmaceuticals Canada Inc.
Sponsor Novartis Pharmaceuticals Canada Inc.
Submission Date September 5, 2012
Submission Deemed Complete September 12, 2012
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ September 19, 2012
Check-point meeting October 31, 2012
pERC Meeting February 21, 2013
Initial Recommendation Issued March 7, 2013
Feedback Deadline ‡ March 21, 2013
pERC Reconsideration Meeting (target date)
Final Recommendation Issued March 25, 2013
Notification to Implement Issued April 11, 2013
Therapeutic Area Advanced 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.