Lartruvo – Notice of Compliance with Conditions - Qualifying Notice
Biologics and Genetic Therapies Directorate
100 Eglantine Driveway
Address Locator #0601C
October 23, 2017 (signed)
Dossier ID: HC6-024-e194220
Control #: 203478
Document # : 1259013
[employee name removed]
Consultant, Regulatory Affairs
Eli Lilly Canada Inc.
3650 Danforth Avenue
Toronto, ON M1N 2E8
Dear [employee name removed]:
This Notice of Compliance with Conditions (NOC/c)-Qualifying Notice, issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the New Drug Submission (NDS) for LARTRUVO (olaratumab), Control Number 203478, qualifies to be considered for authorisation under the NOC/c policy for the following indication:
LARTRUVO (olaratumab) is indicated:
- In combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and for whom treatment with an anthracycline-containing regimen is appropriate.
In keeping with the provisions outlined in the NOC/c policy, the following additional information is required to complete the assessment:
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 NOC/c Policy. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, Eli Lilly 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 Eli Lilly Canada Inc., having a form and content satisfactory to Health Canada, as indicated in the Guidance Document: Notice of Compliance with Conditions (NOC/c), including commitments to provide the following:
- a) Submit, as an SNDS-C, the final clinical study report (CSR) for the confirmatory study JGDJ entitled “A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of Lartruvo plus Doxorubicin versus Doxorubicin plus Placebo in Patients with Advanced or Metastatic Soft Tissue Sarcoma”. The SNDS-C will be submitted by Q3/2020.
- b) Acknowledge that the indication authorized under the NOC/c pathway for Lartruvo under control number 203478 can be withdrawn if the results from Study JGDJ do not demonstrate a positive benefit/risk profile as determined by BGTD.
Progress Reports of Confirmatory Trials and Other Ongoing Trials
- c) Submit, 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 the ongoing confirmatory trial, as per section 3.2 and Appendix 4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Specifically, provide a summary of the status of the Study JGDJ, including updates to the planned study close out date and any subsequent actions taken.
- d) Report all serious Adverse Reactions (ARs) 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 this Letter of Undertaking, will be sent to the Biologics and Genetic Therapies Directorate. Reporting will be conducted 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).
- e) Submit Periodic Benefit-Risk Evaluation Reports for NOC/c Products (PBRER-Cs) on an annual basis until such time as conditions associated with the market authorization are removed. PSUR-Cs/PBRER-Cs will be prepared in accordance with the E2C(R1) and E3C(R2) lCH Guidelines, including format and content, as per section 3.4.2 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- f) Comply with the notification and reporting requirements for specific issues of concern as outlined in Section 3.4.4 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- g) Implement the Risk Management Plan (RMP) in Canada and provide any updates to the RMP whenever available.
- h) Receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional materials related to LARTRUVO (olaratumab) authorized under the NOC/c policy as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- i) Provide an outline of the advertising, labelling and distribution requirements as agreed with Health Canada. Commit to submit revised Product Monographs under the appropriate submission type as information is made available as per section 4.3 of the Guidance Document: Notice o/Compliance with Conditions (NOC/c).
- j) Provide up-to-date, complete listing of ongoing additional clinical trials related to LARTRUVO, is provided as Appendix to this Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
- k) Provide copies of any marketing authorizations or other regulatory actions for LARTRUVO, 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 guidances on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to Guidance Document: Notice of Compliance with Conditions) to the outstanding information within 30 calendar days of the date of this letter.
Your response to the above should be submitted with a copy of this letter to the Office of Submissions and Intellectual Property. 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, and address your response to:
Director, Office of Submissions and Intellectual Property
Therapeutic Products Directorate
101 Tunney's Pasture Driveway
Address Locator 0201A1
Ottawa, Ontario, K1A 0K9
Attention: Office of Regulatory Affairs Biologics and Genetic Therapies Directorate
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