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Cemiplimab (Libtayo) for Cutaneous Squamous Cell Carcinoma — Details

Project Number pCODR 10187
Brand Name Libtayo
Generic Name Cemiplimab
Strength 50mg/mL
Tumour Type Skin & Melanoma
Indication Cutaneous Squamous Cell Carcinoma
Funding Request For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.
Review Status Pending
Pre Noc Submission No
NOC Date
Manufacturer Sanofi Genzyme
Submitter Sanofi Genzyme
Submission Date (Target Date) July 9, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ July 23, 2019
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.