Qualifying notice for Kymriah
Biologic and Radiopharmaceutical Drugs Directorate
100 Eglantine Driveway
Tunney’s Pasture, A.L. 0601C
Ottawa ON K1A 0K9
Dossier ID: HC6-024-e204549
Control #: 263500
[Employee name removed]
[Employee title removed]
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, QC H9S 1A9
[Employee email removed]
[Employee name removed]:
This Notice of Compliance with Conditions (NOC/c)-Qualifying Notice, issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the Supplemental New Drug Submission (SNDS) for Kymriah (Tisagenlecleucel) Control Number 263500, indicated for adult patients with relapsed or refractory 1, 2, 3a follicular lymphoma (FL) after two or more lines of systemic therapy, qualifies to be considered for authorisation under the NOC/c policy. In keeping with the provisions outlined in the NOC/c policy, the following additional information is required to complete the assessment:
- A letter, signed by the Chief Executive Officer, or designated signing authority of Novartis Pharmaceuticals Canada Inc., indicating that you agree to have this submission considered under the NOC/c Policy. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, Novartis Pharmaceuticals consents to the posting of the NOC/c-QN on Health Canada's website.
- A draft Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority, of Novartis Pharmaceuticals Canada Inc., having a form and content satisfactory to Health Canada, as indicated in the Guidance Document: Notice of Compliance with Conditions (NOC/c), including commitments to provide the following:
- Provide a randomized Phase III study in patients with r/r FL. Patients should be randomized to tisagenlecleucel or investigator’s choice of treatment consistent with the standard of care. The primary endpoint should be progression free survival with secondary endpoints that include overall survival and overall response rate. The Letter of Undertaking should provide an estimate of key dates such as the expected date of study completion, and the expected date of submission to Health Canada.
Progress reports of confirmatory trials and other ongoing trials
- on an annual basis, within 60 calendar days of the market authorization anniversary or a date agreed upon at the time of the issuance of the market authorization, status reports on the progress of ongoing confirmatory trials, as per section 3.2 and Appendix 4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). The details of the requirements for filing and termination of the annual status report as agreed upon by the Novartis Pharmaceuticals Canada Inc. and Health Canada must be outlined in the Letter of Undertaking.
- report all serious Adverse Reactions (AR) that occur in Canada and all serious unexpected ARs that occur outside of Canada within 15 days to the Marketed Health Products Directorate. Adverse Events (AE) and AR reports on marketed drugs occurring as part of confirmatory trials subject to clinical trial applications, as outlined in the Letter of Undertaking, must be sent to the Biologic and Radiopharmaceutical Drugs Directorate. Reporting must be conducted as per section 3.4.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c) and in accordance with current regulations and guidelines (e.g. Guidance for Industry: Reporting Adverse Reactions to Marketed Health Products and the Guidance for Clinical Trial Sponsors: Clinical Trial Applications).
- Periodic Safety Update Reports or Periodic Benefit-Risk Evaluation Reports-C for NOC/c Products (PSUR-Cs or PBRER-Cs) on an annual basis until such time as conditions associated with the market authorisation are removed. PSUR-Cs/PBRER-Cs should be prepared in accordance with the E2C(R1) and E3C(R2) ICH Guideline, including format and content, as per section 3.4.2 of the Guidance Document: Notice of Compliance with Conditions (NOC/c);
- comply with the notification and reporting of specific issues of concern as outlined in Section 3.4.4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material related to Kymriah (Tisagenlecleucel) authorized under the NOC/c policy as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- an outline of the agreed-upon advertising, labelling or distribution requirements, including a commitment to file revised Product Monographs under the appropriate submission type as information is made available as per section 4.3 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- an up-to-date, complete listing of ongoing additional clinical trials related to Kymriah (Tisagenlecleucel) appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- copies of any marketing authorizations for Kymriah (Tisagenlecleucel) from any other drug regulatory authority as per Section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidances on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to Guidance Document: Notice of Compliance with Conditions) to the outstanding information within 30 calendar days of the date of this letter.
Your response to the above should be submitted with a copy of this letter to the Office of Submissions and Intellectual Property. In order to facilitate and ensure proper processing of your response, please quote the product name, assigned dossier ID, and control number of the original submission, and send directly to the Office of Submissions and Intellectual Property (OSIP) via the Common Electronic Submissions Gateway (CESG) using the Regulatory Enrolment Process (REP).
Celia Lourenco, Ph.D.
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