2024-11-04 15:35:00
Pharmaceutical Medicines Directorate
Holland Cross, Tour B
1600 Scott Street, 6th floor
3106B Address Locator
Ottawa ON K1A 0K9
File number: HC6-024-e196129
Control number: 278618
Servier Canada Inc.
[nom de l’employé enlevé]
Head of Regulatory Affairs and Quality Assurance
3224 Jean-Beraud Avenue, Suite 270
Laval QC H7T 2S4
Fax: 450-781-1430
Madame [nom de l’employé enlevé]:
This notice of eligibility for a notice of compliance with conditions (AA-AC-C), issued in accordance with Health Canada’s Guidance: Notice of Compliance with Conditions (NOC-C), is intended to inform you that the Information submitted in support of the Supplement to a New Drug Submission (SNDS) for Folotyn (pralatrexate injection), control number 278618, is eligible for approval under the guidance noted above for the following indication: treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
In accordance with the provisions of this guideline, the following additional information is required to complete the evaluation of your presentation:
A letter, signed by the CEO or designated signing officer of Servier Canada Inc. indicating that you agree to have the submission reviewed under the Guidance: Notice of Compliance with Conditions (NOC-C). Please remember that by agreeing to receive a Notice of Compliance (NOC) under this guideline, Servier Canada Inc. consents to the posting of this AA-NOC-C on the Health Canada website once the marketing authorization received. A draft letter of commitment signed by the CEO or designated signing officer of Servier Canada Inc., the format and content of which satisfies Health Canada, as indicated in the Guidance Document: Notice of Compliance with Conditions ( AC-C), and stating in particular a commitment to provide the following information:
Confirmatory studies
Submit interim and final reports for the confirmatory trial titled SPI-BEL-301: Randomized, Open-Label Phase III Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in patients newly diagnosed with peripheral T-cell lymphoma. Full data-driven clinical study reports (CSRs) at predefined milestones should be submitted with all supporting data sets. RECs should confirm the objective response rate (ORR) and contain reliable estimates of time-of-event parameters, including duration of response (DR), progression-free survival (PFS), and overall survival. (SG). Indicate the approximate date for completion of Part 1 (dosage determination) of SPI-BEL-301 and commit to establishing an approximate date for filing the interim report with the results of Part 1. Indicate the approximate date completion of Part 2 (efficacy and safety) of SPI-BEL-301 and commit to establishing an approximate date for submission of the final report of the confirmatory trial.
Annual progress reports on confirmatory studies
Annual progress reports on the progress of ongoing confirmatory studies must be submitted within 60 days of the date of issuance of the marketing authorization or on a date agreed upon at the time of issuance of the marketing authorization. marketed, 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 the submission of the annual progress report and its termination, as agreed by Servier Canada Inc. and Health Canada, must be indicated in the engagement letter.
Safety Monitoring
Report all serious adverse reactions (AEs) that occurred in Canada and all serious unexpected AEs that occurred outside of Canada within 15 days to the Marketed Health Products Directorate. Reports of adverse events and AEs related to marketed drugs occurring during confirmatory studies subject to clinical trial applications, as indicated in the letter of commitment, must 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 directives (for example, Reporting of adverse reactions to marketed health products – Guidance document for industry and the Guidance for Clinical Trial Sponsors: Clinical Trial Applications). Submit periodic pharmacovigilance reports or periodic benefit-risk assessment reports for products associated with a NOC-C (RPPV-C or RPEAR-C) each year, until the conditions associated with the marketing authorization be withdrawn. RPPV-C/RPEAR-C should be prepared based on the ICH E2C (R2) guidelines, including format and content, in accordance with section 3.4.2 of the Guidance: Notice of compliance with conditions (AC-C). Please note that once all commitments have been fulfilled, Periodic Benefit and Risk Assessment Reports – Pharmacovigilance (RPEAR-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 authorization holder identifies negative safety findings or significant changes in the overall benefit-risk and pharmacovigilance profiles of the product. Implement and maintain a risk management plan (RMP) in accordance with guidelines published by Health Canada. Comply with the notification and reporting of concerns on specific issues, in accordance with section 3.4.4 of the Guidance: Notice of Compliance with Conditions (NOC-C).
Additional information
Obtain prior authorization from the Pharmaceutical Advertising Advisory Council (PAAB) for all promotional materials relating to Servier Canada Inc., in accordance with section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC-C). For more information on regulatory advertising requirements, please see: Provide copies of all marketing authorizations for Servier Canada Inc. granted by any other drug regulatory authority, in accordance with section 4.6 of the Guidance: Notice of Compliance with Conditions (NOC-C).
I would like to inform you that this notice of eligibility is issued under the Guideline: Management of drug submissions and requests and the Guideline: Notice of compliance with conditions (NOC-C) respectively.
Please submit all missing information (see Guidance: Notice of Compliance with Conditions (NOC-C) in the 30 calendar days following the date of this letter, directly to the Office of Submissions and Intellectual Property (BPPI), through the Common Electronic Application Portal, using the Regulatory Registration Process.
To facilitate and ensure proper processing of your response, please indicate the product name, the file number assigned to it, and the control number of the original submission.
Please accept the expression of my best regards.
Karen Reynolds
General Director
Pharmaceutical Medicines Directorate
1730754607
#Modified #eligibility #notice #Folotyn
**Interview with Dr. Ana Martinez, Head of Regulatory Affairs at Servier Canada Inc.**
**Interviewer:** Thank you for joining us today, Dr. Martinez. We just received news about Health Canada’s Notice of Compliance with Conditions for Folotyn. Can you explain what this means for patients?
**Dr. Martinez:** Thank you for having me. The Notice of Compliance with Conditions, or NOC/c, represents a significant step forward in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. It allows us to market Folotyn while continuing to collect additional data on its efficacy and safety. This will ultimately help patients who have limited treatment options.
**Interviewer:** Could you elaborate on what specific commitments Servier Canada Inc. has agreed to under this NOC/c?
**Dr. Martinez:** Certainly. As part of this approval, we are required to conduct confirmatory studies. We will be monitoring the effectiveness and safety of Folotyn in a randomized trial against standard treatments. We need to provide interim and final reports, including data on objective response rates and survival metrics. Regular progress reports to Health Canada will also be a part of our commitments.
**Interviewer:** What kind of safety monitoring will be in place now that Folotyn is eligible for marketing?
**Dr. Martinez:** Safety is a top priority for us. We are obligated to report any serious adverse reactions that occur in Canada within a tight 15-day window. We’ll also be submitting periodic benefit-risk assessment reports every year until we satisfy all the conditions of the marketing authorization. Should any serious safety issues arise during our ongoing studies, they will be communicated promptly to regulators.
**Interviewer:** What are the next steps now that you have received this notice?
**Dr. Martinez:** Our immediate focus will be on finalizing our commitments related to the confirmatory studies. We will also be preparing the required documentation to ensure compliance with Health Canada’s guidelines. It’s critical that we demonstrate the real-world efficacy and safety of Folotyn while making it available to patients who need it.
**Interviewer:** how do you think this development impacts the future of treatment for peripheral T-cell lymphoma?
**Dr. Martinez:** This is a promising moment for both healthcare professionals and patients. By advancing the availability of Folotyn, we aim to provide a new therapeutic avenue that could significantly improve patient outcomes. If our studies yield positive results, it could pave the way for broader approvals and a deeper understanding of how to manage this challenging condition.
**Interviewer:** Thank you for your insights, Dr. Martinez. We look forward to following the progress of Folotyn and its impact on patient care.
**Dr. Martinez:** Thank you for having me, and we appreciate your interest in advancing patient health!
