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Avelumab (Bavencio) for Urothelial Carcinoma - Details

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.