The following table summarises the key steps and dates for this application.
This evaluation was facilitated through Project Orbis, an initiative of the United States (US) Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). Under this project, the FDA, Health Canada (HC) and the TGA collaboratively reviewed the application. This innovative evaluation process provided a framework for process alignment and management of evaluation issues in real-time across jurisdictions.
Each regulator agency maintained its regulatory process to make independent decisions about the approval (market authorisation).
|Designation (Orphan)||9 January 2020|
|Submission dossier accepted and first round evaluation commenced||2 March 2020|
|First round evaluation completed||31 July 2020|
|Sponsor provides responses on questions raised in first round evaluation||30 September 2020|
|Second round evaluation completed||28 October 2020|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||19 October 2020|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||29 October 2020|
|Completion of administrative activities and registration on ARTG||2 November 2020|
|Number of working days from submission dossier acceptance to registration decision*||123|
*Statutory timeframe for standard applications is 255 working days
Prior to initiation of Inqovi 35/100, conduct baseline laboratory testing including complete blood cell counts with platelets, serum hepatic panel, and serum creatinine. Obtain complete blood cell counts prior to start of each cycle.
The recommended dose of Inqovi 35/100 is 1 tablet containing 35 mg of decitabine and 100 mg of cedazuridine taken orally once daily on Day 1 through 5 of each 28-day cycle for a minimum of 4 cycles. Best response may take longer than 4 cycles. Continue treatment as long as the patient continues to benefit. Repeat cycles every 28 days in the absence of haematologic toxicities not attributed to active disease and blood counts show absolute neutrophil count at least 1000/μL and platelets at least 50000/μL, or at least return to pretreatment levels. Delay or reduce the dose per cycle for haematologic toxicity.
For further information refer to the Product Information.
Inqovi 35/100 (decitabine and cedazuridine) was approved for the following therapeutic use:
Inqovi 35/100 is indicated for the treatment of adult patients with myelodysplastic syndromes (MDS) intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups, and patients with chronic myelomonocytic leukaemia (CMML).
- Inqovi 35/100 (decitabine 35 mg and 100 mg cedazuridine) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Inqovi 35/100 must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Inqovi 35/100 core management plan (risk management plan) (version 1.1, dated 25 August 2020, data lock point 19 March 2019), with Australian Specific Annex (ASA) (version 1.1, dated September 2020), included with submission PM-2020-00088-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the European Union (EU) during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.