Imbruvica - Notice of Compliance with Conditions - Qualifying Notice - 2015 - Health Canada

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

Dossier ID: E157271

June 24, 2015

[employee name removed]
Senior Associate, Regulatory Affairs
Janssen Inc.
19 Green Belt Drive
TORONTO, Ontario
M3C 1L9

Notice of Compliance with Conditions (NOC/c) - Qualifying Notice

Dear [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 IMBRUVICA (ibrutinib), Control number 179136, for the indication in patients with relapsed or refractory mantle cell lymphoma (MCL), 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 Janssen 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/c under the NOC/c policy, Janssen 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 Janssen Inc., having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to supply the following:

   Confirmatory Studies

   To confirm the clinical benefit of Imbruvica for the treatment of patients with relapsed or refractory mantle cell lymphoma, Janssen Inc. will submit the following:

   • A. A final analysis report of Study PCYC-1104-CA with a minimum follow-up of 24 months for each patient. If 24 months follow-up is not possible for specific patients, a justification should be provided for each patient.
   • B. The final study report for PCI-32765MCL2001: a Phase II study (n = 120) in subjects with MCL who have received at least 1 rituximab-containing chemotherapy regimen and who progressed after at least 2 cycles of bortezomib therapy.
   • C. The final study report for PCI-32765MCL3001: a randomized Phase III study (n = 280) of Imbruvica versus temsirolimus in subjects with relapsed or refractory mantle cell lymphoma who have received at least 1 prior rituximab-containing chemotherapy.

   Post Marketing Safety Monitoring Studies

   • D. 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.

   • E. 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

   • F. Provide an up-to-date, complete listing of ongoing additional clinical trials related to Imbruvica (ibrutinib), 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 risk communication letter, detailing the issuance of a Notice of Compliance in accordance with the NOC/c Guidance for the indication of Imbruvica (ibrutinib) for the treatment of patients with relapsed or refractory mantle cell lymphoma.

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.

Sincerely,

Barbara J. Sabourin
Director General

BJS/oh