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Qualifying notice for Retevmo (298049)

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

Dossier ID: e233861
Control number: 298049

Eli Lilly Canada Inc
[name of employee removed]
Director-Global Regulatory Affairs
Suite 900, Exchange Tower, 130 King Street West Po Box 73
Toronto ON M5X 1B1
Fax: 416-693-3547

Dear [name of employee 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 Retevmo (selpercatinib), Control Number 298049, qualifies to be considered for authorization in accordance with the above guidance document for the following indication:

Retevmo (selpercatinib) is indicated as monotherapy for the treatment of:

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 Eli Lilly 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), Eli Lilly 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 Eli Lilly 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. The final report of study LIBRETTO-431 (J2G-MC-JZJC): A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
    • To provide substantial evidence for confirming that Retevmo is associated with an improved clinical benefit compared to currently marketed therapies in Canada for patients with metastatic RET fusion-positive NSCLC.
    • Based on the similarity of the underlying biology driving both RET fusion-positive thyroid cancers and RET fusion-positive NSCLC, the results from LIBRETTO-431 in patients with RET fusion-positive NSCLC could provide data to support the clinical benefit of selpercatinib in patients with RET fusion-positive thyroid cancer.
  2. The final report of study LIBRETTO-531 (J2G-MC-JZJB): A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer
    • To provide substantial evidence for confirming that Retevmo is associated with an improved clinical benefit compared to currently marketed therapies in Canada for patients with advanced or metastatic RET-mutant MTC. The results of the efficacy endpoints "progression-free survival" and "overall survival" will be used to confirm the improved clinical benefit. The primary endpoint "Treatment failure-free survival" is not considered to be sufficient for confirming the clinical effectiveness of selpercatinib.
    • To provide confirmatory results supporting the clinical benefit of Retevmo for the treatment of adolescent patients with advanced or metastatic RET-mutant MTC.
  3. The final report of study LIBRETTO-121 (LOXO-RET-18036): A Phase 1/2 Study of the oral RET inhibitor LOXO-292 in pediatric patients with advanced RET-altered solid or primary central nervous system tumors
    • To support the clinical benefit of Retevmo for the treatment of adolescent patients with advanced or metastatic RET-mutant MTC.
  4. An integrated analysis of the clinical benefit of Retevmo in pediatric patients 12 years and older from LIBRETTO-001, LIBRETTO-531 and LIBRETTO-121 that further characterizes the efficacy of Retevmo and its potential serious risk of long-term adverse effects of selpercatinib on growth and development.

Progress reports of confirmatory trials

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 Eli Lilly 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. Adverse Events (AE) and AR reports on marketed drugs occurring as part of confirmatory trials subject to clinical trial applications, as outlined in the Letter of Undertaking, must be reported as per section 3.4.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c) and in accordance with current regulations and guidelines (e.g. Guidance for Industry: Reporting Adverse Reactions to Marketed Health Products and the Guidance for Clinical Trial Sponsors: Clinical Trial Applications).
  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(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. Receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material related to Retevmo (selpercatinib) as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). For more information on the regulatory requirements for advertising, please visit: Regulatory Requirements for Advertising.
  2. An up-to-date, complete listing of ongoing additional clinical trials related to Retevmo (selpercatinib), appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  3. Copies of any marketing authorizations for Retevmo (selpercatinib) from any other drug regulatory authority as per Section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).

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 quote the product name, assigned dossier ID and control number of the original submission.

Yours sincerely,

Kelly Robinson
Director General
Pharmaceutical Drugs Directorate

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2026-01-14