2023-04-17 19:54:00
Directorate of Biological and Radiopharmaceutical Medicines
100 Eglantine Driveway
LCDC Building
Pre Tunney, AI 0601C
Ottawa ON K1A 0K9
According to the file: HC6-024-e244848
Control No: 265517
[Nom de l’employé enlevé]
[Titre de l’employé enlevé]
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga IS L5N 5M8
E-mail: [Courriel de l’employé enlevé]
Madame [Nom de l’employé enlevé],
This notice of eligibility for a Notice of Compliance with Conditions (AA-NOC-C), issued in accordance with Health Canada’s Guidance Document: Notice of Compliance with Conditions (NOC-C), is intended to inform you that information submitted in support of the new drug submission [PDN] for Columvi (glofitamab), control number 265517, indicated for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (FTL) or mediastinal lymphoma primitive B-cell therapy (LMPCB), who have received at least two lines of systemic therapy and who cannot or are not eligible for CAR-T cell therapy, or who have previously received CAR-T cell therapy, are eligible for approval under the above guideline. In accordance with the provisions of this guideline, the following additional information is required to complete the assessment process:
- A letter, signed by the CEO or designated signing officer of Hoffmann-La Roche Limitée, stating that you consent to the submission being reviewed under the Guideline: Notice of Compliance with Conditions (NOC/C). Remember that by agreeing to receive a Notice of Compliance (NOC) under this guidance, Hoffmann-La Roche Limitée consents to the posting of the NOA-NOC-C on Health Canada’s website a once marketing authorization has been received.
- A draft letter of commitment signed by the CEO or designated signing authority of Hoffmann-La Roche Limitée, in a format and content satisfactory to Health Canada, as set out in the Guidance Document: Notice of Compliance with Conditions ( AC-C), and stating in particular a commitment to provide the following information:
Confirmatory studies
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The sponsor should commit to submitting a clinical trial to provide confirmatory evidence of efficacy in the setting of relapsed or refractory diffuse large B-cell lymphoma. Specifically, the main analyzes of the study titled as follows: A randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of glofitamab in combination with gemcitabine and oxaliplatin compared to rituximab in combination with gemcitabine and oxaliplatin (GemOx) in patients with relapsed or refractory diffuse large B-cell lymphoma should be submitted to Health Canada as a Supplemental New Drug Submission – Confirmation (SNDS c).
Of note, the primary efficacy objective of the Phase III study is to demonstrate that glofitamab plus GemOx is associated with better overall survival compared to rituximab plus GemOx. The sponsor should acknowledge that the authorization of glofitamab may be revoked if the trial fails to improve the primary outcome.
- The sponsor must provide an estimated date of completion of the primary analyzes for the study mentioned in point a as well as an expected date for the submission of the study to Health Canada.
Confirmatory Testing Progress Reports
- Annual progress reports on the progress of ongoing confirmatory trials must be submitted within 60 days of the date of issuance of the marketing authorization or by a date agreed upon at the time of issuance of the marketing authorization. marketing, in accordance with section 3.2 and appendix 4 of the Guideline: 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 Hoffmann-La Roche Limited and Health Canada, should be set out in the Letter of Engagement.
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 marketed drug-related adverse events and adverse reactions occurring during confirmatory trials subject to clinical trial applications, as set out in the Letter of Undertaking, must be reported in accordance with Section 3.4. 1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c) and according to applicable regulations and guidelines (for example, Guidance Document for Industry: Reporting of Adverse Reactions to Marketed Health Products and Guidance for Clinical Trial Sponsors: Clinical Trial Applications).
- Submit Periodic Safety Update Reports or Periodic Benefit-Risk Assessment Reports for NOC-C (RPPV-C or RPEAR-C) products every 6 (six) months until associated conditions marketing authorization be withdrawn. RPPV-C/RPEAR-C should be prepared according to International Council on Harmonization (ICH) E2C(R1) and E3C(R2) guidelines, including format and content, as per section 3.4.2 of the Guideline: Notice of Compliance with Conditions (NOC-C). Please note that once all commitments have been fulfilled, Periodic Benefit-Risk Assessment Reports – Pharmacovigilance (RPEAR-PV) or Periodic Pharmacovigilance Reports (RPPV-PV) must be submitted as per regulations. (subsection C.01.018(4)), upon request or in situations where the MAH identifies negative safety findings or significant changes in the overall benefit-risk and pharmacovigilance profiles of the product.
- Comply with notification and report on specific issues of concern, in accordance with section 3.4.4 of the Guidance: Notice of Compliance with Conditions (NOC/C).
Additional Information
- Obtain pre-clearance from the Pharmaceutical archyde news Advisory Board (PAAB) for all promotional material relating to Columvi (glofitamab) in accordance with section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/C). For more information on regulatory requirements for , please visit: https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements- .html.
- Provide a complete and up-to-date list of additional ongoing clinical trials with Columvi (glofitamab), as an appendix to the draft Letter of Undertaking, as per section 4.5 of the Guidance Document: Notice of Compliance with conditions (AC-C).
- Provide copies of all marketing authorizations for Columvi (glofitamab) 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 Eligibility 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 Guideline: 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 (OIP), by through the Common Electronic Application Portal (ECSP), using the Regulatory Enrollment Process (REP).
In order 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, Madame, the expression of our distinguished sentiments.
Michael Rosu-Myles, Ph.D.
Acting General Manager
1681770472
#Notice #eligibility #columvi #Canada.ca
