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Decitabine-Cedazuridine (Inqovi) for MDS - Details

Project Number PC0228-000
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 with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups.
Review Status Suspended
Clarification The timeline of the review has been temporarily suspended, pending the receipt of additional information from the sponsor.
Pre Noc Submission No
NOC Date July 7, 2020
Manufacturer Taiho Pharma Canada, Inc.
Sponsor Taiho Pharma Canada, Inc.
Submission Date October 9, 2020
Submission Type Initial
Prioritization Requested
Stakeholder Input Deadline ‡ October 26, 2020
Check-point meeting January 14, 2021
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
Therapeutic Area Myelodysplastic Syndromes (MDS)

‡ 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.