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Cemiplimab (Libtayo) for Cutaneous Squamous Cell Carcinoma — Details

Project Number PC0187-000
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 Complete
Pre Noc Submission No
NOC Date April 10, 2019
Manufacturer Sanofi Genzyme
Sponsor Sanofi Genzyme
Submission Date July 9, 2019
Submission Deemed Complete July 30, 2019
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ July 23, 2019
Check-point meeting September 17, 2019
pERC Meeting December 12, 2019
Initial Recommendation Issued January 3, 2020
Feedback Deadline ‡ January 17, 2020
pERC Reconsideration Meeting (target date)
Final Recommendation Issued January 22, 2020
Notification to Implement Issued February 6, 2020
Therapeutic Area Advanced Cutaneous Squamous Cell Carcinoma (CSCC)
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.