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|Project Number||pCODR 10171|
|Strength||840 mg/14 mL & 1200 mg/20 mL|
|Indication||Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)|
|Funding Request||In combination with nab-paclitaxel for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1, and who have not received prior chemotherapy for metastatic disease. Maintenance TECENTRIQ should be continued until disease progression or unacceptable toxicity.|
|Clarification||Hoffmann-La Roche Limited has requested a voluntary withdrawal of the pCODR 10171 Atezolizumab (Tecentriq) for MBC submission.|
|Pre Noc Submission||No|
|NOC Date||September 19, 2019|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||October 2, 2019|
|Submission Deemed Complete||October 17, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||October 17, 2019|
|Check-point meeting||December 18, 2019|
|pERC Meeting (target date)|
|Initial Recommendation Issued (target date)|
|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.