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Giotrif for Advanced Non Small Cell Lung Cancer - Details

Project Number PC0032-000
Brand Name Giotrif
Generic Name Afatinib
Strength 20mg, 30mg, and 40mg tablets
Tumour Type Lung
Indication Advanced Non Small Cell Lung Cancer
Funding Request For the first line treatment of EGFR Mutation Positive, Advanced Non-Small Cell Lung Cancer patients
Review Status Complete
Pre Noc Submission Yes
NOC Date November 1, 2013
Manufacturer Boehringer Ingelheim Canada Ltd.
Sponsor Boehringer Ingelheim Canada Ltd.
Submission Date June 7, 2013
Submission Deemed Complete June 19, 2013
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ June 21, 2013
Check-point meeting September 30, 2013
pERC Meeting February 20, 2014
Initial Recommendation Issued March 6, 2014
Feedback Deadline ‡ March 20, 2014
pERC Reconsideration Meeting April 17, 2014
Final Recommendation Issued May 2, 2014
Notification to Implement Issued May 20, 2014
Clarification A delay in the receipt of Category 2 Part 2 requirements has impacted the review timeline.
Therapeutic Area Advanced or Metastatic Non-Small Cell Lung Cancer
Recommendation Type Reimburse

‡ 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.