2024-05-17 17:30:00
Directorate of Organic Medicines and Radiopharmaceuticals
100, Promenade Eglantine
LCDC constructing
Pre Tunney, IA 0601C
Ottawa ON K1A 0K9
File quantity: HC6-024-e270264
Management quantity: 278277
[Nom de l’employé enlevé]
[Le titre de l’employé enlevé]
Janssen Inc.
19 Inexperienced Belt Drive
Toronto ON M3C 1L9
E-mail : [adresse e-mail de l’employé enlevé]
[Nom de l’employé enlevé],
This discover of eligibility for a discover of compliance with circumstances (AA-AC-C), issued in accordance with Well being Canada’s Steerage: Discover of Compliance with Circumstances (NOC-C), is meant to tell you that the Data submitted in help of the New Drug Submission (NDS) for Talvey (talquetamab injection), management quantity 278277, is eligible for approval below the steering famous above for the next indication: remedy grownup sufferers with relapsed or refractory a number of myeloma who’ve acquired no less than three prior traces of remedy, together with a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who’ve skilled illness development throughout or after the final remedy. In accordance with the provisions of this guideline, the next further data is required to finish the evaluation course of:
A letter, signed by the CEO or designated signing officer of Janssen Inc., indicating that you simply comply with have the submission reviewed below the Steerage: Discover of Compliance with Circumstances (NOC-C). Please do not forget that by agreeing to obtain a Discover of Compliance (NOC) below this steering, Janssen Inc. consents to the posting of the AA-NOC-C on the Well being Canada web site as soon as the advertising authorization acquired. A draft letter of dedication signed by the CEO or designated approved signatory Janssen Inc., the format and content material of which satisfies Well being Canada, as indicated within the Steerage Doc: Discover of Compliance with Circumstances (NOC- C), and stating specifically a dedication to offer the next data:
Confirmatory research
Submit, as a Complement to a New Drug Submission — Affirmation (SPDN-C), the scientific examine report (CSR) of the examine entitled: Randomized part 3 examine evaluating talquetamab SC together with daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Mixture With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd), in Members With Recurrent A number of Myeloma or refractory having acquired no less than one prior line of remedy (MonumenTAL-3).
The report should comprise a main evaluation of the first outcomes, progression-free survival (PFS) and the outcomes of an noticed survival (OS) evaluation permitting a significant evaluation of the OS good thing about teclistamab-based remedy with in comparison with the management remedy.
The timelines related to this testing, together with an estimate of the SPDN-C date, have to be indicated within the dedication letter.
Confirmatory Trial Progress Experiences
Annual progress experiences on the progress of ongoing confirmatory trials have to be submitted inside 60 days of the date of issuance of the advertising authorization or on a date agreed upon on the time of issuance of the advertising authorization. marketed, in accordance with part 3.2 and Appendix 4 of the Steerage Doc: Discover of Compliance with Circumstances (NOC-C). Particulars relating to the necessities for the submission of the annual progress report and its termination, as agreed by Janssen Inc. and Well being Canada, have to be indicated within the engagement letter.
Security Monitoring
Report all severe opposed reactions (AEs) that occurred in Canada and all severe sudden AEs that occurred exterior of Canada inside 15 days to the Marketed Well being Merchandise Directorate. Experiences of opposed occasions and opposed reactions associated to marketed medication occurring throughout confirmatory trials topic to scientific trial purposes, as indicated within the letter of dedication, have to be reported in accordance with part 3.4. 1 of the Steerage Doc: Discover of Compliance with Circumstances (NOC-C) and in accordance with relevant laws and directives (for instance, Steerage doc for business: Reporting of opposed reactions to marketed well being merchandise and the Steerage for Medical Trial Sponsors: Medical Trial Functions). Periodic pharmacovigilance experiences or periodic profit and danger evaluation experiences (RPPV-C or RPEAR-C) have to be established throughout the first three years following advertising: each six months throughout the first two years of promoting authorization, plus an annual RPPV-C/RPEAR-C throughout the third 12 months of promoting in Canada; RPPV-C/RPEAR-C have to be ready in accordance with the E2C(R2) theme of the Worldwide Convention on Harmonization (ICH), significantly with regard to format and content material, in accordance with part 3.4.2 of the road guideline: Discover of Compliance with Circumstances (NOC-C). Please be aware that after all commitments have been met, Periodic Profit-Threat Analysis and Pharmacovigilance Experiences (RPEAR-PV) or Periodic Pharmacovigilance Experiences (RPPV) have to be submitted in accordance with the laws (paragraph C. 01.018(4)), upon request or in conditions the place the advertising authorization holder signifies damaging security findings or vital adjustments within the general benefit-risk and pharmacovigilance profiles of the product. product. Adjust to notification and report on particular problems with concern, in accordance with part 3.4.4 of the Steerage: Discover of Compliance with Circumstances (NOC-C).
Further Data
Receive prior approval from the Pharmaceutical Promoting Advisory Council (PAAB) for all promotional supplies regarding Talvey (talquétamab injection) in accordance with part 5.1 of the Steerage Doc: Discover of Compliance with Circumstances (NOC-C). For extra data on regulatory promoting necessities, please see: Present an entire and up-to-date checklist of further ongoing scientific trials involving Talvey (talquétamab injection), as an appendix to the draft letter of request. dedication, in accordance with part 4.5 of the Guideline: Discover of Compliance with Circumstances (NOC-C). Present copies of all Talvey (talquétamab injection) advertising authorizations granted by every other drug regulatory authority, in accordance with part 4.6 of the Steerage Doc: Discover of Compliance with Circumstances (NOC-C).
I want to inform you that this discover of eligibility is issued below the Guideline: Administration of drug submissions and requests and the Guideline: Discover of compliance with circumstances (NOC-C) respectively.
Please submit all lacking data (see Steerage Doc: Discover of Compliance with Circumstances (NOC-C)) inside 30 calendar days of the date of this letter, on to the Workplace of Submissions and Mental Property (BPPI), by via the Frequent Digital Functions Portal (CEAP), utilizing the Regulatory Registration Course of (RIP).
To facilitate and guarantee correct processing of your response, please point out the product title, the file quantity assigned to it, and the management variety of the unique submission.
Please settle for, Madam, the expression of our distinguished emotions.
Sophie Summers
Govt Director
1715981921
#Discover #eligibility #Talvey