Qualifying notice: Truseltiq
Therapeutic Products Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
Dossier ID: e243204
[employee name removed]
[employee title removed]
QED Therapeutics, Inc.
8000 Marina Boulevard Suite 400
Dear [employee name removed]
This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Truseltiq (infigratinib phosphate), control number 246904, for the indication of treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement, qualifies to be considered for authorization in accordance with the NOC/c Guidance. In keeping with the provision outlined in the NOC/c Guidance, the following additional information is required to complete the assessment:
- A letter, signed by the Chief Executive Officer or designated signing authority of QED Therapeutics, Inc., indicating that you agree to have this submission considered under the NOC/c Guidance. Please be reminded that in agreeing to accept a Notice of Compliance (NOC) under the NOC/c Guidance, QED Therapeutics, Inc. consents to the posting of this NOC/c-QN on Health Canada's website once market authorization has been received.
- A Letter of Undertaking signed by the Chief Executive Officer or designated signing authority of QED Therapeutics, Inc. having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to provide the following:
Submit, as a SNDS-c, the final study report for confirmatory study titled [trial identifier removed] - A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib Versus Gemcitabine With Cisplatin in Subjects With Advanced/Metastatic or Inoperable Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations.
- QED Therapeutics, Inc. should provide the approximate date of completion of the confirmatory study and should commit to an approximate date of filing of the SNDS-c.
- QED Therapeutics, Inc. should acknowledge that the indication authorized under NOC/c pathway for Truseltiq under control# 246904 can be withdrawn or revised if [trial identifier removed] does not demonstrate an improvement in efficacy, compared with Gemcitabine plus Cisplatin that is both statistically and clinically significant.
Post market safety monitoring studies
- Provision of annual Periodic Benefit-Risk Evaluation Reports (PBRER-Cs) or Periodic Safety Update Reports (PSUR-Cs) in a manner deemed consistent with E2C ICH Guidelines, until such time as all conditions for market authorization under the NOC/c Guidance have been removed. The annual PBRER-Cs or PSUR-Cs should include cumulative data on relevant unlisted Adverse Reactions (ARs) from the date of marketing to the time of the report.
- Notification and reporting on specific issues of concern, as outlined in Section 3.4.4, Post-Market Commitments: Notification and Reporting of Specific Issues of Concern, of the Health Canada NOC/c Guidance.
- Report(s) of all serious adverse drug reactions (ADRs) that occurred in Canada and all serious unexpected ADRs that occurred outside of Canada should be forwarded within 15 days to the Marketed Health Products Directorate, in accordance with the current Food and Drug Regulations (C.01.017) and guidance documents.
- A draft of the Product Monograph (PM) that is consistent with the requirements outlined in section 5.2.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Please note that boxed text should appear on the cover page as well as at the beginning of each major section of the Product Monograph (Parts I, II and III, as applicable), disclosing the nature of the authorization granted for Truseltiq for the indication of treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
- A final mock-up of the Package Insert (if applicable), in line with the requirements outlined in Health Canada's Guidance Document, Questions and Answers: Plain Language Labelling Regulations (Q&A: PLL), containing boxed text disclosing the nature of the authorization granted for Truseltiq for the indication of treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance documents on the Management of Drug Submissions and Applications and Notice of Compliance with Conditions. Sponsors are instructed to submit a complete response [refer to Guidance Document: Notice of Compliance with Conditions (NOC/c)] with the requested information within 30 calendar days of the date of this letter.
In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to the Office of Submissions and Intellectual Property, Therapeutic Products Directorate, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Tunney's Pasture, Ottawa, Ontario, K1A 0K9.
Dr. J. Patrick Stewart, MD, CCFP(EM)
Therapeutic Products Directorate
Report a problem or mistake on this page
- Date modified: