2024-09-20 18:10:00
Directorate of Biological and Radiopharmaceutical Medicines
100, Eglantine promenade
LCDC building
Pré Tunney, I.A. 0601C
Ottawa ON K1A 0K9
File number: E271976
Control number: 281963
[nom de l’employé enlevé]
[le titre de l’employé enlevé]
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga ON L5N 0A4
E-mail : [adresse de l’employé enlevé]
[nom de l’employé enlevé]:
This Notice of Compliance with Conditions (NOC-C) Qualifying Notice, issued in accordance with Health Canada’s Guidance Document: Notice of Compliance with Conditions (NOC/c), is to inform you that the information submitted in support of a Supplemental New Drug Submission (SNDS) for Imdelltra (tarlatamab), Control Number 281963, is eligible for approval under the above-noted guidance document for the following indication: Imdelltra (tarlatamab for injection) is indicated for the treatment of adults with extensive-stage small cell lung cancer (SCLC) that has progressed on or after at least two prior therapies, including platinum-based chemotherapy. In accordance with the provisions of this guidance document, the following additional information is required to complete the assessment process:
A letter, signed by the Chief Executive Officer or designated signing authority of Amgen Canada Inc., indicating that you agree to have the submission reviewed under the Guidance Document: Notice of Compliance with Conditions (NOC/c). Please note that by agreeing to receive a Notice of Compliance (NOC) under this Guidance Document, Amgen Canada Inc. consents to the posting of the NOC/c on Health Canada’s website once market authorization is received. A draft commitment letter signed by the Chief Executive Officer or designated signing authority of Amgen Canada Inc., in a format and content satisfactory to Health Canada, as outlined in the Guidance Document: Notice of Compliance with Conditions (NOC/c), including a commitment to provide the following information:
Confirmatory studies
To provide the full clinical study report for the DeLLphi-304 study (protocol 2021004), a phase 3, randomized, open-label study of tarlatamab compared to standard of care in subjects with relapsed small cell lung cancer following first-line platinum-based chemotherapy.
Progress reports on confirmatory trials
Annual progress reports on the conduct of ongoing confirmatory trials must be submitted within 60 days of the date of issuance of the marketing authorization or at a date agreed upon at the time of issuance of the marketing authorization, in accordance with section 3.2 and Appendix 4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Details regarding the requirements for submission of the annual progress report and its termination, as agreed to by Amgen Canada Inc. and Health Canada, must be set out in the Letter of Undertaking.
Safety monitoring
Report all serious adverse reactions (ARs) that occurred in Canada and all serious unexpected ARs that occurred outside of Canada within 15 days to the Marketed Health Products Directorate. Reports of adverse events and adverse reactions related to marketed drugs occurring during confirmatory trials subject to clinical trial applications, as outlined in the Letter of Undertaking, should be reported in accordance with section 3.4.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c) and in accordance with applicable regulations and guidelines (for example, Guidance for Industry: Reporting Adverse Reactions to Marketed Health Products and Guidance for Clinical Trial Sponsors: Clinical Trial Applications). Periodic safety reports or periodic benefit-risk evaluation reports-C for NOC-c products (PSUR-C or PSEAR-C) every six months for the first two years of marketing authorisation and then annually for one additional year. PSUR-C/PSEAR-C should be prepared according to the International Council on Harmonisation (ICH) E2C(R2) guidelines, including format and content, in accordance with section 3.4.2 of the Guidance Document: Notice of Compliance with Conditions (NOC-c). Please note that once all commitments have been met, Periodic Benefit-Risk Evaluation Reports – Pharmacovigilance (PBEAR-PV) or Periodic Pharmacovigilance Reports (RPPV-PV) must be submitted in accordance with the regulations (paragraph C.01.018(4)), upon request or in situations where the marketing authorisation holder identifies adverse safety findings or significant changes in the overall benefit-risk and pharmacovigilance profiles of the product. Comply with the notification and reporting of specific issues of concern, in accordance with section 3.4.4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
Additional information
Obtain prior approval from the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material for Imdelltra (tarlatamab) in accordance with section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). For more information on regulatory requirements for advertising, please see: Provide a complete and up-to-date list of additional ongoing clinical trials for Imdelltra (tarlatamab) as an appendix to the draft Letter of Commitment, in accordance with section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Provide copies of all marketing authorizations for Imdelltra (tarlatamab) granted by any other drug regulatory authority, in accordance with section 4.6 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
I wish to inform you that this Notice of Acceptability is issued under the Guidance Document: Management of Drug Submissions and Applications and the Guidance Document: Notice of Compliance with Conditions (NOC/c) respectively.
Please submit all missing information (see Guidance: Notice of Compliance with Conditions (NOC-c)) within 30 calendar days of the date of this letter, directly to the Office of Submissions and Intellectual Property (OSIP), through the Common Electronic Application Portal (CEAP), using the Regulatory Enrolment Process (REP).
To facilitate and ensure the proper processing of your response, please indicate the name of the product, the file number assigned to it, as well as the control number of the initial submission.
Please accept, Madam, the expression of our distinguished sentiments.
Sophie Summers
General Manager
1726903458
#Imdelltra #Eligibility #Notice #Canada.ca
