FOI release

Freedom of Information request (FOI 22/843)

Published 17 January 2024

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FOI 22/843

1st September 2022

Dear

Thank you for your request under FOIA, we have annotated your email below with our response.

Dear Sirs.

This is a FOIA request to the MHRA regarding:

1) Ibrutinib / Imbruvica SmPC (PLGB 00242/0688 ; PLGB 00242/0689; PLGB 00242/0690 PLGB 00242/0691)

2) FLAIR trial (EudraCT 2013-001944-76 & IRAS 126738)

My questions:

1) SmPC: when was the variation to the ibrutinib SmPC to include the risk of ventricular tachyarrhythmia submitted by Janssen-Cilag Limited

  • If another body submitted the change, please provide their name and the date

Response: Information on variations to the European licence for Imbruvica (ibrutinib) is available at the following links:

https://www.ema.europa.eu/en/documents/procedural-steps-after/imbruvica-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf

https://www.ema.europa.eu/en/medicines/human/EPAR/imbruvica

Updates to the product information for ibrutinib were made regarding the risk of ventricular tachyarrhythmia through procedure EMEA/H/C/PSUSA/00010301/201611 on 22nd June 2017:

https://www.ema.europa.eu/en/documents/scientific-conclusion/imbruvica-h-c-psusa-00010301-201611-epar-scientific-conclusions-grounds-variation-terms-marketing_en.pdf

The relevant new advice was further communicated to healthcare professionals by MHRA through Drug Safety Update on 15th August 2017:

https://www.gov.uk/drug-safety-update/ibrutinib-imbruvica-reports-of-ventricular-tachyarrhythmia-risk-of-hepatitis-b-reactivation-and-of-opportunistic-infections

Response: Please see above for details on the procedural changes published by EMA for Imbruvica

  • FLAIR trial: when was ventricular tachyarrhythmia added to FLAIR trial, both the date when information was made available to
  • Clinicians, and

Response: Cardiac arrhythmias, including ventricular tachyarrhythmia, were first listed in the version of the trial Reference Safety Information (RSI) that was approved in July 2018. However, MHRA cannot confirm exactly when the RSI would have been made available to trial clinicians for use, as the sponsor would have a process to follow after approval of the substantial amendment to disseminate the updated information to investigators.

  • Trial participants

Response: The MHRA is unable to confirm when information on ventricular tachyarrhythmia was made available to trial participants as we do not review patient-facing information as part of our regulatory process; this responsibility falls to the Research Ethics Committee.

  • MHRA: What information is available on Adverse Drug Reactions from Ibrutinib / Imbruvica

Response: The MHRA is transparent in the data it receives via the Yellow Card scheme. For suspected side effects being reported, the MHRA publishes this information in the form of interactive Drug Analysis Profiles (iDAPs) . The iDAP for ibrutinib can be accessed using the link below:

https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000805115288.zip&agency=MHRA

It is important to note that reported adverse reactions have not been proven to be related to the drug, and should not be interpreted as a list of known side effects..

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

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Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

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