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Avelumab for metastatic Merkel Cell Carcinoma – Details

Project Number pCODR 10124
Brand Name TBD
Generic Name Avelumab
Strength 20 mg/mL
Tumour Type Skin & Melanoma
Indication metastatic Merkel Cell Carcinoma
Funding Request For the treatment of mMCC in previously treated adults
Review Status Under Review
Pre Noc Submission Yes
NOC Date December 18, 2017
Manufacturer EMD Serono - Pfizer Alliance
Submitter EMD Serono - Pfizer Alliance
Submission Date October 10, 2017
Submission Deemed Complete October 17, 2017
Submission Type New Drug
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ October 24, 2017
Check-point meeting December 4, 2017
pERC Meeting (target date) February 15, 2018
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.