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Sonidegib (Odomzo) for Basal Cell Carcinoma - Details

Project Number pCODR 10215
Brand Name Odomzo
Generic Name Sonidegib
Tumour Type Skin and Melanoma
Indication Basal Cell Carcinoma (BCC)
Funding Request For the treatment of patients with metastatic basal cell carcinoma (BCC) or with locally advanced BCC who have measurable metastatic disease or locally advanced disease, which is considered inoperable or inappropriate for surgery and inappropriate for radiotherapy
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Sun Pharma Canada Inc.
Sponsor Sun Pharma Canada Inc.
Submission Date (Target Date) June 15, 2020
Clarification The Submitter notified pCODR that they will be unable to submit by their original target date and an updated target submission date has been provided.
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ June 29, 2020
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.