Qualifying notice for Tabrecta

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

Dossier ID: HC6-024-E251588
Control #: 255972

Novartis Pharmaceuticals Canada Inc.
[Employee name removed]
[Employee title removed]
385 Bouchard Boulevard
Dorval QC H9S 1A9
[Company Fax removed]
[Employee email removed]

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 Tabrecta (capmatinib hydrochloride), control number 255972, indication for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations qualifies to be considered for authorization in accordance with the above guidance document. In keeping with the provisions outlined in the Guidance Document: Notice of Compliance with Conditions (NOC/c), the following additional information is requested to complete the assessment:

  1. A letter, signed by the Chief Executive Officer or designated signing authority of Novartis Pharmaceuticals Canada Inc., indicating that you agree to have this submission considered under the Guidance Document: Notice of Compliance with Conditions (NOC/c). Please be reminded that in agreeing to accept a Notice of Compliance (NOC) under the Guidance Document: Notice of Compliance with Conditions (NOC/c), Novartis Pharmaceuticals Canada Inc. consents to the posting of this NOC/c-QN on Health Canada's website once market authorization has been received.
  2. A draft Letter of Undertaking signed by the Chief Executive Officer or designated signing authority of Novartis Pharmaceuticals Canada Inc., having a form and content satisfactory to Health Canada, as indicated in Guidance Document: Notice of Compliance with Conditions (NOC/c), including commitments to provide the following:

Confirmatory studies

  1. Submit, as a SNDS-c, the interim study report for [study name/number has been removed] as of data cutoff (DCO): 30-Aug-2021 to confirm and further characterize the clinical benefit of capmatinib for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations, by providing a more precise estimation of the blinded independent central review-assessed overall response rate (ORR) and duration of response. This report will contain data from patients with NSCLC harbouring MET exon 14 skipping alterations; data from treatment-naïve patients, after all responders have been followed for at least 12 months from the date of initial response (or until disease progression, whichever occurs first); and from previously treated patients, after all responders have been followed for at least 6 months from the date of initial response (or until disease progression, whichever occurs first).
    1. Novartis Pharmaceuticals Canada Inc. should provide the approximate date of completion of the confirmatory study and should commit to an approximate date of filing of the SNDS-c.
    2. Novartis Pharmaceuticals Canada Inc. should acknowledge that the indication authorized under the NOC/c pathway for Tabrecta under control # 255972 can be withdrawn or revised if the aforementioned results do not confirm clinical benefit of capmatinib for the treatment of adult patients with locally advanced unresectable or metastatic NSCLC harbouring MET exon 14 skipping alterations who are treatment-naïve and who have previously received systemic therapy.

Progress reports of confirmatory trials

  1. On an annual basis, within 60 calendar days of the market authorization anniversary or a date agreed upon at the time of the issuance of the market authorization, status reports on the progress of ongoing confirmatory trials, as per section 3.2 and Appendix 4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). The details of the requirements for filing and termination of the annual status report as agreed upon by the Novartis Pharmaceuticals Canada Inc., and Health Canada should be outlined in the Letter of Undertaking.

Safety monitoring

  1. Report all serious Adverse Reactions (AR) that occur in Canada and all serious unexpected ARs that occur outside of Canada within 15 days to the Marketed Health Products Directorate.
  2. Periodic Safety Update Reports or Periodic Benefit-Risk Evaluation Reports-C for NOC/c Products (PSUR-Cs or PBRER-Cs) on an annual basis until such time as conditions associated with the market authorisation are removed. PSUR-Cs/PBRER-Cs should be prepared in accordance with the E2C(R1) and E3C(R2) ICH Guideline, including format and content, as per section 3.4.2 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Please note that once all the commitments are fulfilled, Periodic Benefit-Risk Evaluation Reports-Pharmacovigilance (PBRER-PV) or Periodic Safety Update Reports-Pharmacovigilance (PSUR-PV) should be submitted as stipulated in the regulations (subsection C.01.018(4)), upon request or in situations where the Market Authorization Holder (MAH) identifies any negative safety findings and/or significant change in the product's overall benefit-risk and safety profiles.
  3. Comply with the notification and reporting of specific issues of concern as outlined in Section 3.4.4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).

Additional information

  1. Novartis Pharmaceuticals Canada Inc. should commit to filing a submission to provide the primary analysis report of [study name/number has been removed]. Novartis Pharmaceuticals Canada Inc. should provide the approximate date of completion of the study and should commit to an approximate date of filing of the submission.
  2. Receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material related to Tabrecta (capmatinib hydrochloride), as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). For information on the regulatory requirements for advertising, refer to Regulatory Requirements for Advertising
  3. An up-to-date, complete listing of ongoing additional clinical trials related to Tabrecta (capmatinib hydrochloride), appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  4. Copies of any marketing authorizations for Tabrecta (capmatinib hydrochloride), from any other drug regulatory authority as per Section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  1. A draft of the Product Monograph that is consistent with the requirements in accordance with the Guidance Document: Product Monograph (2020) and the Product Monograph Master Template, disclosing the nature of the authorization granted for Tabrecta (capmatinib hydrochloride), and the need to conduct confirmatory trials.
  2. A final mock-up of the Package Insert (if applicable), in line with the requirements outlined in Health Canada's Guidance Document, Questions and Answers: Plain Language Labelling Regulations (Q&A: PLL), containing boxed text disclosing the nature of the authorization granted for Tabrecta (capmatinib hydrochloride), for the indication of the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.

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 Applications and Notice of Compliance with Conditions (NOC/c), respectively.

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 directly to the Office of Submissions and Intellectual Property (OSIP) via the Common Electronic Submissions Gateway using Regulatory Enrolment Process.

In order to facilitate and ensure proper processing of your response, please include a revised Submission Certificate, quoting the product name, assigned dossier ID and control number of the original submission.

Yours sincerely,

Dr. J. Patrick Stewart, MD, CCFP(EM)

Director General
Therapeutic Products Directorate
JPS/ap

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