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Avelumab for metastatic Merkel Cell Carcinoma – Details

Project Number pCODR 10124
Brand Name TBD
Generic Name Avelumab
Tumour Type Other
Indication metastatic Merkel Cell Carcinoma
Funding Request For the treatment of adult patients with mMCC
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer EMD Serono - Pfizer Alliance
Submitter EMD Serono - Pfizer Alliance
Submission Date (Target Date) October 10, 2017
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ October 24, 2017
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (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.