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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 adult patients with histologically confirmed locally advanced basal cell carcinoma (laBCC) that is not amenable to radiation therapy or curative surgery.
Review Status Under Review
Pre Noc Submission Yes
NOC Date
Manufacturer Sun Pharma Canada Inc.
Sponsor Sun Pharma Canada Inc.
Submission Date June 19, 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 Deemed Complete July 23, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline ‡ July 6, 2020
Check-point meeting September 15, 2020
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.