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Project Number | pCODR 10115 |
---|---|
Brand Name | Tecentriq |
Generic Name | Atezolizumab |
Strength | 60 mg/mL |
Tumour Type | Lung |
Indication | Non-Small Cell Lung Cancer |
Funding Request | For the treatment of patients with locally advanced or metastatic non-small cell lung cancer who have progressed on or after systemic chemotherapy until loss of clinical benefit |
Review Status | Notification to Implement Issued |
Pre Noc Submission | Yes |
NOC Date | April 6, 2018 |
Manufacturer | Hoffmann-La Roche Limited |
Sponsor | Hoffmann-La Roche Limited |
Submission Date | December 15, 2017 |
Submission Deemed Complete | December 22, 2017 |
Submission Type | New Drug |
Prioritization Requested | Not Requested |
Stakeholder Input Deadline ‡ | January 8, 2018 |
Check-point meeting | February 13, 2018 |
pERC Meeting | May 17, 2018 |
Initial Recommendation Issued | June 1, 2018 |
Feedback Deadline ‡ | June 15, 2018 |
Final Recommendation Issued | June 20, 2018 |
Notification to Implement Issued | July 6, 2018 |
‡ 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.