Lorbrena - Notice of Compliance with Conditions - Qualifying Notice
Therapeutic Product Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
Dossier ID: E188115
[employee name removed]
Manager, Regulatory Affairs
Pfizer Canada Inc.
17,300 Trans-Canada Highway
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 LORBRENA (lorlatinib), control number 215733, indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib, 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:
The recommendation to issue a NOC/c-QN for lorlatinib is based upon promising evidence from [trial identifier removed]. The following post-authorization commitments (NOCc-QN) have been requested:
- A letter, signed by the Chief Executive Officer or designated signing authority of Pfizer Canada Inc., indicating that they agree to have this submission considered under the NOC/c Guidance. The sponsor has been reminded that in agreeing to accept an NOC under the NOC/c Guidance, Pfizer Canada Inc consents to the posting of the NOC/c-QN on Health Canada's website.
- A draft Letter of Undertaking signed by the Chief Executive Officer or designated signing authority of Pfizer Canada Inc, having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to supply the following:
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:
“Confirmatory trial [trial identifier removed], an ongoing, Phase 3, randomized, open-label trial comparing the safety and efficacy of lorlatinib to crizotinib in the first-line treatment of subjects with advanced ALK+ NSCLC will be the post-approval commitment to confirm the proposed indication for LORBRENA (lorlatinib) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib”.
[trial timeline removed]
Post Market Safety Monitoring Studies
- Provision of semi-annual Periodic Safety Update Reports (PSUR-Cs) or Periodic Benefit Risk Evaluation Reports (PBRER-Cs) in a manner deemed consistent with E2C ICH Guidelines, until such time as all conditions for the Canadian Reference Product market authorizations under the NOC/c policy have been removed. The PSUR-Cs or PBRER-Cs should include cumulative data on relevant unlisted Adverse Reactions (ARs) from the date of marketing to the time of the report.
- Notification and reporting on specific issues of concern as outlined in Section 3.4.4, Post-Market Commitments: Notification and Reporting of Specific Issues of Concern, of the Health Canada NOC/c revised policy dated June 30, 2011.
- Reports of all serious ARs that occurred in Canada and all serious unexpected ARs that occurred outside of Canada should be forwarded within 15 days to the Marketed Health Products Directorate, in accordance with current regulations and Guidelines (Guidelines for Reporting Adverse Reactions to Marketed Drugs, March, 2011).
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
Finance Building Address Locator 0201A1
101 Tunney’s Pasture Driveway,
Dr. J. Patrick Stewart, MD, CCFP(EM)
Therapeutic Products Directorate
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