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| Project Number | PC0225-000 |
|---|---|
| Brand Name | Bavencio |
| Generic Name | Avelumab |
| Strength | 20 mg/mL |
| Tumour Type | Genitourinary |
| Indication | Urothelial Carcinoma (UC) |
| Funding Request | Bavencio is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy. |
| Review Status | Notification to Implement Issued |
| Pre Noc Submission | Yes |
| NOC Date | December 10, 2020 |
| Manufacturer | EMD Serono - Pfizer Alliance |
| Sponsor | EMD Serono - Pfizer Alliance |
| Submission Date | September 18, 2020 |
| Submission Deemed Complete | October 2, 2020 |
| Submission Type | Initial |
| Prioritization Requested | |
| Stakeholder Input Deadline ‡ | October 2, 2020 |
| Check-point meeting | November 27, 2020 |
| pERC Meeting | February 18, 2021 |
| Initial Recommendation Issued | March 4, 2021 |
| Feedback Deadline ‡ | March 18, 2021 |
| Final Recommendation Issued | March 23, 2021 |
| Notification to Implement Issued | April 8, 2021 |
| Therapeutic Area | Urothelial Carcinoma (UC) |
‡ 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.
