Qualifying notice for Jemperli

Untitled Document

Biologic and Radiopharmaceutical Drugs Directorate
100 Eglantine Driveway
LCDC Building
Tunney's Pasture, A.L. 0601C
Ottawa ON K1A 0K9

Dossier ID: HC6-024-e242880
Control #: 251105

[Employee name removed]
[Employee title removed]
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga ON L5N 6L4
Email: [Employee email address removed]

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 Jemperli (dostarlimab) Control Number 251105, indicated as a monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen, qualifies to be considered for authorisation under the NOC/c policy. In keeping with the provisions outlined in the NOC/c policy, the following additional information is required to complete the assessment:

  1. A letter, signed by the Chief Executive Officer, or designated signing authority of GlaxoSmithKline 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, GlaxoSmithKline Inc. consents to the posting of the NOC/c-QN on Health Canada's website.
  2. A draft Letter of Undertaking signed by the Chief Executive Officer or designated signing authority of GlaxoSmithKline 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:

Confirmatory study

Clinical efficacy and safety conditions/commitments:

  1. Confirmatory Study [study name/number has been removed]:
    • In order to confirm the efficacy and safety of dostarlimab in adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen the MAH should submit the results of the [study name/number has been removed], comparing the efficacy and safety of dostarlimab in combination with chemotherapy to chemotherapy alone in patients with recurrent or advanced endometrial cancer who have not received prior systemic anticancer therapy for recurrent or advanced disease.

      The Clinical Study Report (CSR) should be submitted by: December 31, 2022.

  2. [study name/number has been removed]:
    • In order to confirm the efficacy and safety of dostarlimab in adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen the MAH should submit additional data and updated results of the ongoing [study name/number has been removed], Cohort A1, including additional patients (expansion of enrolment) with measurable disease followed for at least 12 months from the onset of response.

      The CSR should be submitted by: December 31, 2022.

  3. Clinical pharmacology conditions/commitments:
    • Due to the limited number of patients who tested positive for anti-drug antibody (ADA), no conclusions can be drawn concerning a potential effect of immunogenicity on clinical pharmacology, efficacy and safety of Jemperli. The sponsor should commit to monitoring and analyzing immunogenicity in Jemperli clinical trials.
    • Patients with moderate or severe hepatic impairment or severe renal impairment were not adequately represented in the [study name/number has been removed]. The sponsor should commit to monitoring and analyzing Jemperli safety in these patient populations. In the next appropriate regulatory submission for Jemperli, provide an integrated exposure-response analysis for all patients with liver and kidney impairment if data become available from clinical trials.
  4. Post-marketing conditions/commitments:
    1. The sponsor is requested to include the following in the Risk Management Plan (RMP):
      • Canadian epidemiological data related to the prevalence, trends in the incidence and mortality in patients with endometrial cancer in the Canadian addendum.
    2. The sponsor is requested to provide biannual Periodic Benefit-Risk Evaluation Reports (PBRERs) for 2 years. PBRER-Cs should be prepared in accordance with the E2C(R1) and/or 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).

Progress reports of confirmatory trials and other ongoing 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) should be provided. The details of the requirements for filing and termination of the annual status report, as agreed upon by the GlaxoSmithKline Inc. and Health Canada, must 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 sent to the Biologic and Radiopharmaceutical Drugs Directorate. Reporting must 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).
  2. Periodic Safety Update Reports for NOC/c Products (PSUR-Cs) should be filed on an annual basis until such time as conditions associated with the market authorisation are removed. PSUR-Cs should be prepared in accordance with the E2C(R1) and/or 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).
  3. The Risk Management Plan (RMP) should be implemented in Canada and any updates to the RMP provided whenever available.

Additional information

  1. GlaxoSmithKline Inc. should receive pre-clearance by the Pharmaceutical Advertising Advisory Board (PAAB) for all promotional material related to Jemperli (dostarlimab) authorized under the NOC/c policy as per section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  2. Provide an up-to-date, complete listing of ongoing GSK sponsored clinical trials related to Jemperli (dostarlimab), appended to the draft Letter of Undertaking, as per Section 4.5 of the Guidance Document: Notice of Compliance with Conditions (NOC/c).
  3. Provide copies of any marketing authorization(s) for Jemperli (dostarlimab), 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
Resource Management and Operations Directorate
Address Locator: 1908A
8th Floor – Room 811A Jeanne Mance Building
200 Eglantine Driveway
Ottawa ON K1A 0K9

Attention:
Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate

Sincerely,

Celia Lourenco, Ph.D.
Director General

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