Notice of Eligibility for Lynparza – Canada.ca

2023-08-03 14:50:00

Pharmaceutical Drugs Directorate
Holland Cross, Tour B
1600 Scott Street, 6th Floor
3106B Address Locator
Ottawa ON K1A 0K9

File number: HC6-024-e167204
Control number: 265427

[nom de l’employé enlevé]
[le titre de l’employé enlevé]

AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga ON L4Y 1M4
Fax number: 905-275-6271

Dear [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 Supplemental New Drug Submission (SNDS) for Lynparza (olaparib), control number 265427, indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), carriers of a deleterious or presumed deleterious germline and/or somatic mutation of a BRCA gene, in whom chemotherapy is not clinically indicated (the presence of a BRCA mutation must be confirmed prior to initiating treatment with Lynparza), 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 evaluation of your submission:

1. A letter, signed by the CEO or designated signing authority of AstraZeneca Canada Inc stating that you agree to the submission being reviewed under the Guideline: Notice of Compliance with Conditions (NOC/C). Please remember that by agreeing to receive a Notice of Compliance (NOC) under this guidance, AstraZeneca Canada Inc consents to the posting of this NOA-NOC-C on Health Canada’s website once marketing authorization received.
2. A draft letter of commitment signed by the Chief Executive Officer or designated signing authority of AstraZeneca Canada Inc, in 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

1. To confirm clinical benefit in the mutant BRCA gene subgroup, submit the final efficacy analysis (end of Q4 2023) from the Phase 3 PROpel study as confirmation of the Supplement to a submission of New Drug – Confirmation (SNDS-C). Analyzes should verify and describe the clinical benefit of olaparib plus abiraterone acetate and prednisone with respect to overall survival in the BRCA gene subgroup.

Annual progress reports on confirmatory studies

2. Annually, within 60 calendar days of the anniversary of the marketing authorization or on a date agreed at the time of the issuance of the marketing authorization and confirmatory trial progress reports in courses, in accordance with section 3.2 and appendix 4 of the Guideline: Notice of Compliance with Conditions (NOC/C). Details of the requirements for submission and completion of the annual progress report, agreed to by AstraZeneca Canada Inc. and Health Canada, should be outlined in the letter of engagement.

Safety monitoring

3. Report, within 15 days, all serious adverse reactions (ARs) that occur in Canada and all serious and unexpected adverse reactions that occur outside of Canada to the Marketed Health Products Directorate. Reports of adverse events (AEs) and IRs on marketed drugs that occur in confirmatory trials submitted in clinical trial applications, as outlined in the Letter of Undertaking, should 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 guidelines (e.g. Guidance Document for Industry – Reporting of Adverse Reactions to Marketed Health Products and Guidance for Clinical Trial Sponsors: Clinical Trial Applications).
4. Submission of Periodic Safety Update Reports or Periodic Benefit-Risk Assessment-C (RPPV-C or RPEAR-C) reports for two consecutive years following the marketing of this new indication for Lynparza (olaparib) in Canada. Annual RPEAR-Cs or RPPV-Cs should include cumulative data on relevant adverse reactions (ARs) not listed between the date of marketing and the date of the report. RPPV-C or RPEAR-C should be prepared in accordance with the International Council for Harmonization (ICH) E2C(R1) and E3C(R2) Guidelines, including format and content, per section 3.4.2 of the Guideline: Notice of Compliance with Conditions (NOC-C). Please note that when all commitments have been fulfilled, periodic benefit-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 MAH identifies negative safety findings or significant changes in the overall benefit-risk and pharmacovigilance profiles of the product.
5. Comply with 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

6. Obtain pre-clearance from the Pharmaceutical archyde news Advisory Board (PAAB) for all promotional material relating to Lynparza (olaparib), in accordance with section 5.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/C). For more information on regulatory requirements, please see:
7. A complete and up-to-date list of other ongoing clinical trials related to Lynparza (olaparib), as an appendix to the draft Letter of Engagement, as per section 4.5 of the Guidance Document: Notice of Compliance with Conditions ( AC-C).
8. Copies of all marketing authorizations for Lynparza (olaparib) from any other drug regulatory authority, as per section 4.6 of the Guidance: Notice of Compliance with Conditions (NOC/C).

3. A draft product monograph that complies with the requirements of the Guidance Document: Product Monographs (2020) and the Master Product Monograph Template, indicating the nature of the authorization granted for Lynparza (olaparib) and the need to conduct confirmatory studies.
4. A final mock-up of the product package insert (if applicable), conforming to the requirements set out in Health Canada’s Guidance Document: Questions and Answers: Plain Language Labeling Regulations (Questions and Answers: ELC), containing boxed text disclosing the nature of the authorization granted for Lynparza (olaparib) indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer ( CPRCm), carriers of a deleterious or presumed deleterious mutation (germinal and/or somatic) of a BRCA gene, in whom chemotherapy is not clinically indicated. Patients should have confirmation of a BRCA gene mutation before initiating therapy with Lynparza.

I would like to inform you that this Notice of Eligibility is issued pursuant to the Guideline: Management of Drug Submissions and Applications and the Guideline: Notice of Compliance with Conditions (NOC/c) respectively.

Proponents must submit a complete response including the requested information (see Guidance Document: Notice of Compliance with Conditions [AC-C]) within 30 calendar days of the date of this letter, directly to the Office of Submissions and Intellectual Property (OIP), through the Common Electronic Application Portal, using the Regulatory Registration Process.

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 the expression of my best feelings.

Karen Reynolds
Executive Director
Pharmaceutical Drugs Directorate
HRK/oh

1691176646
#Notice #Eligibility #Lynparza #Canada.ca