Qualifying Notice for Istodax

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

Dossier ID: e147777

September 9, 2013

[employee name removed]
Associate Manager, Regulatory Affairs
Celgene Inc.
6755 Mississauga Road, Suite 600
Mississauga, Ontario
L5N 7Y2

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 ISTODAX (romidepsin for injection), control number 152293, for the indication of:

treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy.

Approval is based on response rates demonstrated in a single-arm trial.  Improvement in overall survival has not been demonstrated with Istodax 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:

1. A letter, signed by the Chief Executive Officer or designated signing authority of Celgene Inc, indicating that you agree to have this submission considered under the NOC/c Guidance. Please be reminded that in agreeing to accept an NOC under the NOC/c Guidance, Celgene 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 Celgene Inc, having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to supply the following:

Confirmatory Studies

Final study report of "Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin-CHOP (Ro-CHOP) Versus CHOP in Subjects with Previously Untreated Peripheral T-Cell Lymphoma" should be submitted as confirmatory data.  This study was initiated in January 2013, the trial is anticipated to complete in 2018 and the clinical study report is expected in 2019.

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, 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).

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 ISTODAX for the indication of PTCL.

4. A draft of Part III Consumer Information section of the Product Monograph outlining the potential risks, benefits and side effects of ISTODAX for the indication of PTCL.

5. A draft of the 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 ISTODAX for the indication of PTCL.

In addition, the Bureau requests Celgene Inc. to submit a Supplemental New Drug Submision (SNDS) with the final study report of the following study when available (which should not be considered as a commitment in the Letter of Undertaking):

NCI-9008 Hepatic Impairment Study which will assess the clinical safety of Istodax in patients with advanced cancer and moderate or severe hepatic impairment.

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 informationwithin 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

Yours sincerely,

Original signed by:

Barbara J. Sabourin
Director General

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