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Atezolizumab (Tecentriq) for Advanced or Metastatic Triple-Negative Breast Cancer — Details

Project Number pCODR 10171
Brand Name Tecentriq
Generic Name Atezolizumab
Tumour Type Breast
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.
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Hoffmann-La Roche Limited
Sponsor Hoffmann-La Roche Limited
Submission Date (Target Date) October 2, 2019
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ October 17, 2019
Check-point meeting (target date)
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.