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|Project Number||pCODR 10217|
|Brand Name||Tecentriq & Avastin|
|Generic Name||Atezolizumab & Bevacizumab|
|Indication||Hepatocellular Carcinoma (HCC)|
|Funding Request||TECENTRIQ (atezolizumab), in combination with AVASTIN (bevacizumab), for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Maintenance TECENTRIQ should be continued until loss of clinical benefit or unacceptable toxicity. Maintenance AVASTIN should be continued until disease progression or unacceptable toxicity.|
|Review Status||Under Review|
|Pre Noc Submission||No|
|Manufacturer||Hoffmann-La Roche Limited|
|Sponsor||Hoffmann-La Roche Limited|
|Submission Date||May 21, 2020|
|Submission Deemed Complete||June 4, 2020|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||June 4, 2020|
|Check-point meeting (target date)||August 6, 2020|
|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.