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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 Under Review
Pre Noc Submission No
NOC Date
Manufacturer Sanofi Genzyme
Sponsor Sanofi Genzyme
Submission Date July 9, 2019
Submission Deemed Complete July 30, 2019
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ July 23, 2019
Check-point meeting (target date) September 17, 2019
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.