Avelumab (Bavencio) for Urothelial Carcinoma - Details

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Generic Name:
Avelumab
Project Status:
Complete
Therapeutic Area:
Urothelial Carcinoma (UC)
Manufacturer:
EMD Serono - Pfizer Alliance
Brand Name:
Bavencio
Project Line:
Reimbursement Review
Project Number:
PC0225-000
NOC Status at Filing:
Pre NOC
Strength:
20 mg/mL
Tumour Type:
Genitourinary
Indications:
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
Sponsor:
EMD Serono - Pfizer Alliance
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation:

‡ 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.