Last Updated : May 19, 2017
Details
FilesGeneric Name:
Osimertinib
Project Status:
Complete
Therapeutic Area:
Non-Small Cell Lung Cancer
Manufacturer:
Astra Zeneca Canada Inc
Brand Name:
Tagrisso
Project Line:
Reimbursement Review
Project Number:
PC0076-000
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Strength:
40 mg and 80 mg Tablets
Tumour Type:
Lung
Indications:
Non-Small Cell Lung Cancer
Funding Request:
For the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR TKI therapy
Pre Noc Submission:
Yes
Sponsor:
Astra Zeneca Canada Inc
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Not Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
The timeline of the review was temporarily stopped, pending receipt of the additional information from the submitter. The timeline of the review has resumed as the additional information has now been provided and a new pERC date has been set by pCODR.
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 : May 19, 2017