Cemiplimab (Libtayo) for Cutaneous Squamous Cell Carcinoma — Details

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Generic Name:
Cemiplimab
Project Status:
Complete
Therapeutic Area:
Advanced Cutaneous Squamous Cell Carcinoma (CSCC)
Manufacturer:
Sanofi Genzyme
Brand Name:
Libtayo
Project Line:
Reimbursement Review
Project Number:
PC0187-000
NOC Status at Filing:
Post NOC
Strength:
50mg/mL
Tumour Type:
Skin & Melanoma
Indications:
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.
Sponsor:
Sanofi Genzyme
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation 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.