Qualifying notice: Pemazyre
Therapeutic Products Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
Dossier ID: e242569
[employee name removed]
[employee title removed]
1801 Augustine Cut-Off
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 Pemazyre (pemigatinib), control number 242569, indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) 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 Incyte Corporation, 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, Incyte Corporation 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 Incyte Corporation, having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to provide the following:
Submit, as a Supplement to a New Drug Submission - Confirmatory (SNDS-c), the final study report for the confirmatory study titled: Study INCB54828-302 - A Phase 3, Open-Label, Randomized, Active Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants with Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement.
- Incyte Corporation should provide the approximate date of completion of the confirmatory study and should commit to an approximate date of filing of the SNDS-c.
- Incyte Corporation should acknowledge that the indication authorized under the NOC/c pathway for Pemazyre under control # 242569 can be withdrawn or revised if Study INCB54828-302 does not demonstrate an improvement in efficacy, compared with gemcitabine plus cisplatin chemotherapy that is both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 Pemazyre, for the indication of treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) 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 Pemazyre, for the indication of treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) 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
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