Qualifying Notice - VECTIBIX

Biologics and Genetic Therapies Directorate
200 Tunney's Pasture Driveway
Address Locator #0701A
Ottawa, Ontario
KlA 0K9

File #: 9427-A0969\5-23

February 22, 2008

[Employee's name removed]
Manager, Regulatory Affairs
Amgen Canada Incorporated
6775 Financial Drive, Suite 100
Mississauga, Ontario
L5N 0A4
Fax: 1-866-578-8811

Notice of Compliance with Conditions - Qualifying Notice

Dear [Employee's 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 New Drug Submission (NDS) for VECTIBIX (panitumumab), Control Number 105601, indicated as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens, 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:

  1. A letter, signed by the Chief Executive Officer, or designated signing authority of Amgen Canada Incorporated, 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, Amgen Canada Incorporated 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 Amgen Canada Incorporated, having a form and content satisfactory to Health Canada, as indicated in the Guidance for Industry: Notice of Compliance with Conditions, including commitments to:

    Confirmatory Studies

    1. provide information on the confirmatory trials to investigate efficacy and safety of Vectibix in relation to non-mutated (wild-type) K-RAS in mCRC patients (such as studies 20050181 and 20050203), including:
      • information on the current status and the proposed milestones of the studies;
      • study protocols and protocol amendments as a part of the response to the NOC/c-QN;
      • the statistical analysis plan (SAP) that describes the analysis of the wild-type K-RAS sub-population in these studies, when available. Any input provided by other regulatory agencies on the SAP should be provided and amendments that have been made to the original SAP should be clearly highlighted. The reasons for the amendments should also be provided;
      • the interim, if any, and final clinical study reports, including the efficacy and safety analysis in relation to K-RAS; data on quality of life; the proposed time lines for submitting these reports; and the time lines for completion of these studies; and
      • data on the efficacy and safety of Vectibix in relation to K-RAS in special populations of interest within the clinical study reports, for example, geriatrics.

    2. provide results from the retrospective analysis of efficacy and safety of Vectibix based on the K-RAS status of patients, from the non-pivotal clinical studies 20030167 and 20030250 in a Supplemental New Drug Submission (SNDS). A time line for this SNDS should be indicated.

    3. ensure that the KRAS testing kit is available in Canada before launching the product.

    4. update the Product Monograph (PM) with information on the K-RAS testing kit and state that only the testing kits that have been validated and authorised by Health Canada can be used.

    5. provide information on other on-going trials with Vectibix for the relevant indications including, but not limited to, the STEPP trial, SPIRIT trial and PRECEPT trial. Results of retrospective or prospective analysis of efficacy of Vectibix in relation to the K-RAS mutation status of mCRC patients from these studies should be submitted. The proposed time lines for submitting the study reports should be specified.

    6. provide safety updates for all on-going Vectibix trials.

    7. provide information in relation to communications and consultations with other agencies, when available.

      Post Market Safety Monitoring

    8. provide reports of all serious Adverse Reactions (AR) that occur in Canada and all serious unexpected ARs that occur outside of Canada within 15 days to Health Canada. One copy should be provided to the Marketed Health Products Directorate and another copy to the Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics in the Biologics and Genetic Therapies Directorate in accordance with current regulations and guidelines (e.g. Guidelines for Reporting Adverse Reactions to Marketed Drugs and the Guidance for Industry: Notice of Compliance with Conditions).

    9. submit Periodic Safety Update Reports - for NOC/c Products (PSUR-Cs) for Vectibix (panitumumab) on a semi-annual basis until such time as conditions associated with the market authorisation are removed. PSUR-Cs should be prepared in accordance with the E2C ICH Guideline, including format and content, as per Section 6.2.2 of the Guidance for Industry, Notice of Compliance with Conditions (NOC/c);

    10. implement the Risk Management Plan (RMP) in Canada and provide any updates to the RMP when available.

    11. comply with the notification and reporting of specific issues of concern as outlined in Section 6.2.4 of the Guidance for Industry: Notice of Compliance with Conditions and section 6Eiii of the NOC/c policy.

      Additional information

    12. provide a complete listing of ongoing additional clinical trials related to Vectibix (panitumumab), appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance for Industry: Notice of Compliance with Conditions.

    13. provide copies of any marketing authorisations or other regulatory actions for Vectibix from any other drug regulatory authority as per Section 4.6 of the Guidance for Industry: Notice of Compliance with Conditions.

  3. A draft "Dear Health Care Professional Letter" detailing the issuance of a Notice of Compliance under the NOC/c Policy for Vectibix (panitumumab) indicated as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. [refer to Appendix 3 of the Guidance for Industry: Notice of Compliance with Conditions (NOC/c)].

  4. A draft "Product Specific Fact Sheet" outlining in lay language the potential risks, benefits and side effects of Vectibix (panitumumab) indicated as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. [refer to Appendix 4 of Guidance for Industry: 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 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.

Your response to the above should be submitted with a copy of this letter to the Submission and Information Policy Division. In order to facilitate and ensure proper processing of your response, please include a revised Submission Certificate, quoting the product name, assigned file number and control number of the original submission, and address your response to:

Director, Submission and Information Policy Division
Therapeutic Products Directorate
Finance Building,
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario, K1A 0K9

Attention: Centre for Policy and Regulatory Affairs
BIOLOGICS AND GENETIC THERAPIES DIRECTORATE.

Sincerely,

Original signed by

Dr. Elwyn Griffiths
A/Director General

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