Zydelig - Notice of Compliance with Conditions - Qualifying Notice - 2015

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

March 27, 2015

Dossier ID: E165440

[employee name removed]
Manager, Regulatory Affairs
Gilead Sciences Canada, Inc.
6711 Mississauga Road, Suite 202
MISSISSAUGA, Ontario
L5N 2W3

Notice of Compliance with Conditions - Qualifying Notice

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 ZYDELIG (idelalisib), Control number 172652, indicated as a monotherapy for the treatment of patients with follicular lymphoma who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent, qualifies to be considered for authorization in accordance with the NOC/c Guidance. In keeping with the provisions outlined in the NOC/c Guidance, the following additional information is requested to complete the assessment:

Gilead Sciences Canada, Inc. must submit the following to Health Canada within 30 calendar days of receipt of the NOC/c-QN:

  1. A letter signed by the Chief Executive Officer or designated signing authority of Gilead Sciences Canada, Inc., indicating that you agree to have this submission considered under the NOC/c policy. Please be reminded that in agreeing to accept a NOC under the NOC/c policy, Gilead Sciences Canada, Inc., consents to the posting of the NOC/c-QN on Health Canada's website.
  2. A draft Letter of Undertaking (LoU) signed by the Chief Executive Officer or designated signing authority of Gilead Sciences Canada, Inc., having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to supply the following:
    • Confirmatory Pivotal Studies

      To confirm the longer-term clinical benefit of ZYDELIG as a monotherapy for the treatment of patients with follicular lymphoma who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent, Gilead Sciences Canada, Inc. will submit the following:
      1. Interim topline analysis for the most recent analysis (data cut of 11 June 2014) of Study 101-09, a Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects with Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents.
      2. The final study report for Study 101-09, a Phase 2 Study to Assess the Efficacy and Safety of ZYDELIG in Subjects with Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents. The trial is anticipated to complete in May 2015 and the clinical study report is expected in December 2015.
    • Post Market Safety Monitoring Studies
      1. 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 (MHPD), in accordance with the current Food and Drug Regulations (C.01.017) and guidance documents.
      2. Annual safety summary reports should be provided to the Therapeutic Products Directorate in a manner deemed consistent with the current Guidance Document: Notice of Compliance with Conditions (NOC/c).
    • Additional Information
      1. Provide an up-to-date, complete listing of ongoing additional clinical trials related to ZYDELIG (idelalisib) appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance for Industry: Notice of Compliance with Conditions.
  3. A draft of the "Dear Health Care Professional Letter" detailing the issuance of a Notice of Compliance in accordance with the NOC/c Guidance for ZYDELIG for the indication as a monotherapy for the treatment of patients with follicular lymphoma who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent.
  4. An acceptable draft of Part III Consumer Information section of the ZYDELIG Product Monograph outlining the potential risks, benefits and side effects when ZYDELIG is used as a monotherapy for the treatment of patients with follicular lymphoma who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent.
  5. An acceptable draft of the ZYDELIG Product Monograph 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, if applicable, a boxed text should 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 the indication of ZYDELIG as a monotherapy for the treatment of patients with follicular lymphoma who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent.

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 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:

Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Health Canada
Finance Building Address Locator 0201A1
101 Tunney's Pasture Driveway,
Ottawa, Ontario
K1A 0K9

 

Sincerely,

Original signed by:

Barbara J. Sabourin
Director General

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