SUMMARY OF THE RISK MANAGEMENT PLAN FOR IBRANCE ... · IBRANCE(palbociclib) Pfizer Risk Management...

IBRANCE (palbociclib) PfizerRisk Management Plan Summary April 2019

PFIZER CONFIDENTIAL

SUMMARY OF THE RISK MANAGEMENT PLAN

FOR

IBRANCE (PALBOCICLIB)

Marketing Authorization Number 66138

Version Number: 3.0

Document Date: 02 April 2019

This RMP summary is based on Part VI of the EU RMP for Ibrance (palbociclib), version 1.6, dated 22 February 2019

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PFIZER CONFIDENTIAL

The Risk Management Plan (RMP) is a comprehensive document submitted as part of the application dossier for market approval of a medicine. The RMP summary contains information on the medicine's safety profile and explains the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimise them.

The RMP summary for Ibrance is a concise document and does not claim to be exhaustive.

As the RMP is an international document, the summary might differ from the “Arzneimittelinformation” approved and published in Switzerland, e.g., by mentioning risks occurring in populations or indications not included in the Swiss marketing authorization. Please note that the reference document which is valid and relevant for the effective and safe use of Ibrance® in Switzerland is the “Arzneimittelinformation” (see www.swissmedicinfo.ch) approved and authorised by Swissmedic.

Pfizer is fully responsible for the accuracy and correctness of the content of this published RMP summary for Ibrance.

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PFIZER CONFIDENTIAL

PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN

Summary of risk management plan for Ibrance

This is a summary of the RMP for Ibrance. The RMP details important risks of Ibrance, how these risks can be minimised and how more information will be obtained about Ibrance's risks and uncertainties (missing information).

Ibrance's Summary of Product Characteristics (SmPC) and its Package Leaflet (PL) give essential information to healthcare professionals and patients on how Ibrance should be used.

This summary of the RMP for Ibrance should be read in the context of all this information including the assessment report of the evaluation and its plain-language summary, all which is part of the European Public Assessment Report (EPAR).

Important new concerns or changes to the current ones will be included in updates of Ibrance's RMP.

I. The Medicine and What It Is Used For

Ibrance is authorised for treatment of HR-positive, HER2 negative locally advanced or metastatic breast cancer. It contains Palbociclib as the active substance and it is given by oral route of administration.

Further information about the evaluation of Ibrance’s benefits can be found in Ibrance’s EPAR, including in its plain-language summary, available on the EMA website, under themedicine’s webpage.

II. Risks Associated With the Medicine and Activities to Minimise or Further Characterise the Risks

Important risks of Ibrance, together with measures to minimise such risks and the proposed studies for learning more about Ibrance's risks, are outlined below.

Measures to minimise the risks identified for medicinal products can be:

Specific Information, such as warnings, precautions, and advice on correct use, in the PLand SmPC addressed to patients and healthcare professionals

Important advice on the medicine’s packaging;

The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly;

The medicine’s legal status — the way a medicine is supplied to the public with prescription) can help to minimise its risks.

Together, these measures constitute routine risk minimisation measures.

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In addition to these measures, information about adverse events is collected continuously and regularly analysed, including PSUR assessment so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.

If important information that may affect the safe use of Ibrance is not yet available, it is listed under ‘missing information’ below.

II.A. LIST OF IMPORTANT RISKS AND MISSING INFORMATION

Important risks of Ibrance are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken.

Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Ibrance. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g., on the long-term use of the medicine).

List of important risks and missing information

Important identified risks Myelosuppression (Neutropenia, Anaemia, Thrombocytopenia)ILD/Pneumonitis

Important potential risks QT prolongationHyperglycaemiaReproductive and Developmental Toxicity

Missing information Male patients

II.B. SUMMARY OF IMPORTANT RISKS

Summary of Important Risks or Missing Information

Important Identified Risk: Myelosuppression (Neutropenia, Anaemia, Thrombocytopenia)Evidence for linking the risk to the medicine

Palbociclib non-clinical, clinical studies and Pfizer safety database.

Risk factors and risk groups

Myelosuppression due to palbociclib, a CDK 4/6 inhibitor, is not expected to be as severe or prolonged as for standard cytotoxic chemotherapy (e.g., anthracyclines, alkylating agents, taxanes) based on the mechanism of action of palbociclib. However, decline in overall general health, immune status, intercurrent infections, prior cytotoxic chemotherapy, tumour burden, and other underlying diseases might predispose to or worsen the myelosuppression caused by palbociclib. Refer to VII

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Risk minimisationmeasures

Routine risk minimisation measures: SmPC Sections 4.2, 4.4, 4.8PL Sections 2, 4

Additional risk minimisation measures:None

Important Identified Risk: ILD/PneumonitisEvidence for linking the risk to the medicine

Palbociclib clinical trials and Pfizer safety database


It is currently unknown whether palbociclib is causally associated with the development of ILD/pneumonitis. As such, there are currently no known specific risk groups or risk factors for the development of ILD/pneumonitis in patients receiving palbociclib. Refer to Section SVII.


Routine risk minimisation measures: SmPC Section 4.8PL Section: 4


Additional pharmacovigilance activities

Additional pharmacovigilance activities: None

Important Potential Risk: QT ProlongationEvidence for linking the risk to the medicine

Palbociclib non-clinical, clinical studies and Pfizer safety database.


No specific risk factors have been identified which may predispose patients to develop symptomatic QTc prolongation as a result of treatment with palbociclib.

Based on known general risk factors for QTc prolongation, patient factors that may potentially be associated with an increased risk of developing QTc prolongation under treatment with palbociclib may include pre-existing conditions such as a Long QT Syndrome, a history of cardiac dysrhythmia, electrolyte disturbances, thyroid disorders, cardiac ischaemia, and the concomitant use of medications with the potential to prolong QTc.

Refer to Section VII.Risk minimisationmeasures

Routine risk minimisation measures: SmPC Sections 5.1, 5.3



Additional pharmacovigilance activities: None

Important Potential Risk: HyperglycaemiaEvidence for linking the risk to the medicine

Palbociclib non-clinical and clinical studies.

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PFIZER CONFIDENTIAL



It is unknown if treatment with palbociclib predisposes patients to hyperglycaemia or worsening of diabetes or if palbociclib could enhance the risk of hyperglycaemia or worsening of diabetes due to another drug or illness.


Routine risk minimisation measures: SmPC Section 5.3



Additional pharmacovigilance activities: A5481027

Important Potential Risk: Reproductive and Developmental ToxicityEvidence for linking the risk to the medicine

Palbociclib clinical and non-clinical studies.


No risk groups have been identified.


Routine risk minimisation measures: SmPC Sections 4.6, 5.3PL Section: Pregnancy and breast-feeding and fertility


Missing information: Male patients Risk minimisationmeasures

Routine risk minimisation measures: None


II.C. POST-AUTHORISATION DEVELOPMENT PLAN

II.C.1 STUDIES WHICH ARE CONDITIONS OF THE MARKETING AUTHORISATION

There are no studies that are conditions of the marketing authorisation.

II.C.2 OTHER STUDIES IN POST-AUTHORISATION DEVELOPMENT PLAN

Category 3 (required additional pharmacovigilance activities): 1

A5481027 is a multi-centre, randomised, double-blind, Phase 3 study of palbociclib plus letrozole versus placebo plus letrozole for the treatment of previously untreated Asian post-menopausal women with ER-positive, HER2-negative advanced breast cancer; this CT will also enable the evaluation of any potential effect of palbociclib on hyperglycaemia.

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SUMMARY OF THE RISK MANAGEMENT PLAN FOR IBRANCE ... · IBRANCE(palbociclib) Pfizer Risk Management...

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