Lynparza - Notice of Compliance with Conditions - Qualifying Notice

Therapeutic Product Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
OTTAWA, Ontario
K1A 0K9

Dossier ID: E167204

AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the Supplemental New Drug Submission for LYNPARZA (olaparib), control number 205344, for the indication as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR) BRCA wild type high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy, has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization, qualifies to be considered for authorization in accordance with the NOC/c Guidance. In keeping with the provisions outlined in the NOC/c Guidance, the following additional information is requested to complete the assessment:

1. A letter signed by the Chief Executive Officer or designated signing authority of AstraZeneca Canada Inc. indicating that you agree to have this submission considered under the NOC/c Guidance. Please be reminded that in agreeing to accept an NOC under the NOC/c Guidance, AstraZeneca Canada Inc. consents to the posting of the NOC/c-QN on Health Canada's website.

2. A draft Letter of Undertaking (LOU), signed by the Chief Executive Officer or designated signing authority of AstraZeneca Canada Inc., having a form and content satisfactory to Health Canada, as indicated in NOC/c Guidance, including commitments to supply the following:

Confirmatory Studies

A list of all studies to be conducted to confirm efficacy for the indication authorized in accordance with the NOC/c Guidance. Suggested wording as follows:

"Final study report of the pivotal study entitled [trial identifier removed] should be submitted as confirmatory data". Indicate the earliest availability of the data.

Post Market Safety Monitoring Studies

1. Report(s) of all serious adverse drug reactions (ADRs) that occurred in Canada and all serious unexpected ADRs that occurred outside of Canada should be forwarded within 15 days to the Marketed Health Products Directorate, in accordance with the current Food and Drug Regulations (C.01.017) and guidance documents.
2. Annual Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) should be provided to the Therapeutic Products Directorate in a manner deemed consistent with the current Guidance Document: Notice of Compliance with Conditions (NOC/c).

AstraZeneca Canada Inc. also commits to the following:

3. Active Surveillance

1. Submit reports of all serious and non-serious medication incidents including near misses, reports of concern (potential errors) and complaints that occur in Canada related to confusion between the different formulations of LYNPARZA (olaparib tablets and capsules) for the period during which the tablet and capsule are dually available. The reporting period is to commence with market notification of tablets. Reports are to be submitted to the Canada Vigilance program with a concurrent notification of the ICSR number to the Patient Safety Section (hc.patient.safety-mhpd.sc@canada.ca) in MHPD.
2. Implementation of changes recommended by Health Canada to the documentation regarding the capsule Controlled Distribution Program (CDP) and Patient Support Program (PSP) at the time of olaparib tablet market availability, to prevent errors associated with capsule/tablet substitution. Additionally, registering all patients currently taking or newly prescribed capsules in the PSP.
3. Issuance of a Dear Healthcare Professional (DHP) communication and educational materials for olaparib tablets notifying prescribers and dispensers of the risk of medication confusion/errors and the requirement to report these cases to Health Canada and the manufacturer, and providing updated versions as warranted. These materials will also be made available to the patients/caregivers.

4. A draft of Part III Patient Medication Information section of the Product Monograph outlining the potential risks, benefits and side effects of LYNPARZA (olaparib) tablets for the indication, "monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR) BRCA wild type high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy, has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization".

5. A draft of the Product Monograph that is consistent with the requirements outlined in section 5.2.1 of the Guidance Document: Notice of Compliance with Conditions (NOC/c). Please note that, if applicable, a boxed text should appear on the cover page, at the beginning of each major section of the Product Monograph (Parts I, II and III), the first page, and the start of the Consumer Information section, disclosing the nature of the authorization granted for LYNPARZA (olaparib) tablets for the indication, "monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR) BRCA wild type high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy, has been issued marketing authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization".

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance documents on the Management of Drug Submissions and Notice of Compliance with Conditions. Sponsors are instructed to submit a complete response [refer to Guidance Document: Notice of Compliance with Conditions (NOC/c)] with the requested information within 30 calendar days of the date of this letter.

In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to:

Office of Submissions and Intellectual Property
Therapeutic Products Directorate
Health Canada
Finance Building Address Locator 0201A1
101 Tunney's Pasture Driveway,
Ottawa, Ontario
K1A 0K9

Yours sincerely,

Dr. J. Patrick Stewart, MD, CCFP(EM)
Director General
Therapeutic Products Directorate
JPS/oh