Qualifying Notice for Alunbrig

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

Dossier ID: E205035

[employee name removed] 
[employee title removed] 
Takeda Canada Incorporated
2201 Bristol Circle, Suite 700
Oakville, Ontario
L6H 0J8

Notice of Compliance with Conditions - Qualifying Notice

[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 ALUNBRIG (brigatinib), control number 210369, indicated as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on, or who were intolerant to an ALK inhibitor (crizotinib), 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 Takeda Canada Incorporated, indicating that they agree to have this submission considered under the NOC/c Guidance. Takeda Canada Incorporated has been reminded that in agreeing to accept an NOC under the NOC/c Guidance, Takeda 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 Takeda Canada Incorporated, having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to supply the following:

Confirmatory Trials

A list of all studies to be conducted to confirm efficacy for the indication authorized in accordance with the NOC/c QN Guidance. Suggested wording as follows:

“[trial identifier removed] will be the post-approval commitment to confirm the proposed indication of ALUNBRIG as second line to treatment in patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on, or who were intolerant to an ALK inhibitor (crizotinib) for lifting the conditions for full approval.”

[trial timeline removed]

Other studies negotiated with the sponsor and the review division

Safety and efficacy of ALUINBRIG in weight extremes in ALTA 1L filing.

Post-market commitments, with consideration of the following

The Risk Management Plan (RMP) is acceptable with revisions required within 90 days.

The following should be considered:

Pharmacovigilance Plan Section

  • The RMP should be updated to include a list of the studies requested by the FDA and other regulatory agencies (study numbers, titles, milestones/timelines, and objectives). These include, but not limited to, FDA requested studies:  PMR 3190-2, PMC 3190-5, PMC 3190-6, and PMC 3190-7 and PASS studies requested by the EMA to further characterize the risk of EOPE.
  • Takeda Canada Incorporated should submit to HC updates on these additional PV studies indicated above (could be done in the PSUR reports). In addition, Takeda Canada Incorporated should submit to Health Canada the discussion of the final reports when completed and any changes to the risk minimization measures if applicable.
  • Takeda Canada Incorporated should submit to HC the final reports of the additional PV studies: renal impairment (AP26113-15-108) and the hepatic impairment (AP26113-15-107) once available.
  • Takeda Canada Incorporated should submit to Health Canada an annual PSUR/PBRER two years after marketing in Canada. Takeda Canada Incorporated should present and discuss all information relative to all important risks in the RMP from published literature reports, spontaneous adverse reactions reports and clinical trials in the PBRER as per ICH E2C (R2) guidelines.

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 correspondences 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,

Dr. J. Patrick Stewart, MD, CCFP(EM)
Director General
Therapeutic Products Directorate

JPS/oh

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