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

Project Number PC0171-000
Brand Name Tecentriq
Generic Name Atezolizumab
Strength 840 mg/14 mL & 1200 mg/20 mL
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Review Status Withdrawn
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 Initial
Prioritization Requested
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.