Notice of Compliance with Conditions - Qualifying Notice

2007-06-01

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Contact: BMORS Enquiries

Therapeutic Product Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
Ottawa, Ontario
K1A 0K9

9427-N0846-135

[employee name removed]
Associate, Drug Regulatory Affairs
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Boulevard
Dorval, Quebec
H9S 1A9

[employee name removed]

This Notice of Compliance with Conditions-Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the Supplement to a New Drug Submission for GLEEVEC (imatinib mesylate), Control Number 107659, for the indication of treatment of pediatric patients with newly diagnosed, Philadelphia chromosome-positive, chronic myeloid leukemia (CML) in chronic phase, qualifies to be considered for authorization 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:

1. 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 Canada Inc., consents to the posting of the NOC/c-QN on Health Canada's website.
2. 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 for Industry: Notice of Compliance with Conditions, including commitments to supply the following:
   
   Confirmatory Studies:
   1. Complete molecular response data and confirmation of response durability through the submission of Updated Status Reports containing safety and efficacy information for Study 2108, provided at the earliest availability and March 2008. The requirement for further long term data will be reassessed based on the data submitted within these reports.
   2. Satisfactory fulfillment of commitments contained in the Letter of Undertaking of submission #080591 (GLEEVEC indicated for the treatment of adult patients with newly diagnosed Ph-positive, chronic myeloid leukemia in chronic phase), as study 2108 is considered a bridging study addressing the safety and efficacy of GLEEVEC in the pediatric population.
   Post Market Safety Monitoring Studies:
   1. Report of all serious Adverse Reactions (AR) that occurred in Canada and all serious unexpected ARs that occurred outside of Canada should be forwarded within 15 days to Health Canada. One copy is provided to the Marketed Health Products Directorate and another copy to the appropriate review bureau/centre in the Therapeutic Products Directorate/Biologics and Genetic Therapies Directorate in accordance with current regulations and guidelines.
   2. Periodic Safety Update Reports (PSURs) to be provided in a manner deemed consistent with E2C ICH Guidelines.
3. A draft of the “Dear Health Care Professional Letter” detailing the issuance of a Notice of Compliance under the NOC/c Policy for GLEEVEC for the indication of treatment of pediatric patients with newly diagnosed, Philadelphia chromosome-positive, chronic myeloid leukemia (CML) in chronic phase.
4. A draft of the “Fact Sheet” outlining in lay language the potential risks, benefits and side effects of GLEEVEC for the indication of treatment of pediatric patients with newly diagnosed, Philadelphia chromosome-positive, chronic myeloid leukemia (CML) in chronic phase.
5. A draft of the Product Monograph that is consistent with the requirements outlined in section 5.2.1 of the Notice of Compliance with Conditions Guidance. Please note that, if applicable, a boxed text must appear on the cover page, at the beginning of each major section of the Product Monograph (Parts I, II and III), the first page, and the start of the Consumer Information section, disclosing the nature of the authorization granted for GLEEVEC and the need to conduct confirmatory studies.

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidances and policies on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to "Guidance for Industry; Notice of Compliance with Conditions") to the outstanding 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: Submission and Information Policy Division, Therapeutic Products Directorate, 101 Tunney's Pasture Driveway, Finance Building, A.L. 0201A1, Tunney's Pasture, Ottawa, ON, K1A 0K9.

Yours sincerely,

Original signed by

Supriya Sharma, MD MPH FRCPC
Acting Director General