Atriance - Notice of Compliance with Conditions - Qualifying Notice

Date: 2007-10-23


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

9427-G0838-198

August 10, 2007 (signed)

[employee name removed]
Project Leader, Regulatory Affairs
GlaxoSmithKline Inc.
7333 Mississauga Road North
MISSISSAUGA, Ontario
L5N 6L4

[employee name removed]:

This Notice of Compliance with Conditions-Qualifying Notice, issued in accordance with the Health Canada NOC/c policy, is to advise you that information submitted in support of the New Drug Submission for ATRIANCE, Control Number 099994, qualifies to be considered for approval, 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 GlaxoSmithKline 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, GlaxoSmithKline 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 GlaxoSmithKline 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:

    1. Data from the completed study AALL0434 (Phase III, Paediatric and Adult populations): Intensified Methotrexate, Nelarabine, and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia.

    2. Data from the completed study PGAA107062 (Phase II, Paediatric and Adult populations): Phase II Study with Nelarabine for Patients with refractory or recurrent T-ALL or T-lymphoblastic lymphoma.

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.in accordance with the Guidance for Industry: Notice of Compliance with Conditions.

  2. PSUR REQUIREMENTS REFERENCED IN A MANNER DEEMED APPROPRIATE BY THE REVIEW DIVISION AND CONSISTENT WITH E2C ICH Guideline.

  3. Data from a Post-Marketing Surveillance Study for ATRIANCE in the indicated patient population under 21 years of age receiving the 650mg/m2 dose of nelarabine.

  4. A draft of the "Dear Health Care Professional Letter" detailing the issuance of a Notice of Compliance under the NOC/c Policy for ATRIANCE for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

  5. A draft of the "Fact Sheet" outlining in lay language the potential risks, benefits and side effects of ATRIANCE for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.

  6. 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 ATRIANCE 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 guidance and policy 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 the Submission and Information Policy Division, Therapeutic Products Directorate, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Tunney's Pasture, Ottawa, Ontario, K1A 0K9.

Yours sincerely,

Original signed by

Supriya Sharma, MD MPH FRCPC
Acting Director General

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