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Avelumab (Bavencio) for Urothelial Carcinoma - Details

Project Number pCODR 10225
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 Under Review
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 New Indication
Prioritization Requested
Stakeholder Input Deadline ‡ October 2, 2020
Check-point meeting November 27, 2020
pERC Meeting (target date) February 18, 2021
Initial Recommendation Issued (target date)
Feedback Deadline (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.