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Decitabine-Cedazuridine (Inqovi) for MDS - Details

Project Number pCODR 10228
Brand Name Inqovi
Generic Name Decitabine-Cedazuridine
Tumour Type Leukemia
Indication Myelodysplastic Syndromes (MDS)
Funding Request INQOVI (decitabine and cedazuridine) is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.
Review Status Pending
Pre Noc Submission
NOC Date
Manufacturer Taiho Pharma Canada, Inc.
Sponsor Taiho Pharma Canada, Inc.
Submission Date (Target Date) September 29, 2020
Submission Type New Drug
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ October 14, 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.