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| Project Number | pCODR 10217 |
|---|---|
| Brand Name | Tecentriq & Avastin |
| Generic Name | Atezolizumab & Bevacizumab |
| Strength | 1200 mg/20 mL and 840 mg/14 mL |
| Tumour Type | Gastrointestinal |
| Indication | Hepatocellular Carcinoma (HCC) |
| Funding Request | TECENTRIQ (atezolizumab), in combination with AVASTIN (bevacizumab), for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy. Maintenance TECENTRIQ should continue until loss of clinical benefit or unacceptable toxicity. Maintenance AVASTIN should continue until loss of clinical benefit or unacceptable toxicity. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | August 7, 2020 |
| 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 |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | June 4, 2020 |
| Check-point meeting | August 6, 2020 |
| pERC Meeting | October 15, 2020 |
| Initial Recommendation Issued | October 29, 2020 |
| Feedback Deadline ‡ | November 12, 2020 |
| pERC Reconsideration Meeting (target date) | |
| Final Recommendation Issued | November 17, 2020 |
| Notification to Implement Issued | December 2, 2020 |
‡ 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.
