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Sonidegib (Odomzo) for Basal Cell Carcinoma - Details

Project Number PC0215-000
Brand Name Odomzo
Generic Name Sonidegib
Strength 200 mg
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 No
NOC Date June 12, 2020
Manufacturer Sun Pharma Canada Inc.
Sponsor Sun Pharma Canada Inc.
Submission Date June 19, 2020
Submission Deemed Complete July 23, 2020
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ July 6, 2020
Check-point meeting September 15, 2020
pERC Meeting February 18, 2021
Initial Recommendation Issued March 4, 2021
Feedback Deadline ‡ March 18, 2021
pERC Reconsideration Meeting (target date) April 15, 2021
Final Recommendation Issued (target date) April 29, 2021
Notification to Implement Issued
Therapeutic Area Basal Cell Carcinoma

‡ 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.