AstraZeneca: LinkedIn post and Sunday Times interview found to promote Enhertu for an unlicensed indication (AUTH/3561/9/21)

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Key facts

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Case	AUTH/3561/9/21
Complainant	Ex-employee
Company	AstraZeneca
Medicine	Enhertu (trastuzumab deruxtecan referenced in original LinkedIn post)
Channel(s)	LinkedIn post (personal feed of senior employee); press release; interview leading to Sunday Times article
Main issue	Promotion of Enhertu for an unlicensed indication; exaggerated claims raising unfounded hopes; lack of certification; encouragement for patients to request treatment
Complaint received	24 September 2021
Case completed	19 August 2022
Applicable Code year	2021
Breach clauses	2, 5.1, 6.1, 8.1, 11.2, 26.1, 26.2
No breach clauses	3.1, 11.1, 26.1
Sanctions	Undertaking received; Advertisement
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An ex-employee complained about (1) a senior AstraZeneca employee’s LinkedIn post and (2) a Sunday Times article based on an AstraZeneca press release and an interview with a very senior employee.
The LinkedIn post (edited version dated 21 September 2021) described DESTINY-Breast03 results in HER2-positive metastatic breast cancer as a “landmark moment” and said the “magnitude of benefit… will force us to immediately rewrite the textbooks”.
AstraZeneca said the original LinkedIn post (18 September) had included the generic name trastuzumab deruxtecan and had not been submitted to the Global Nominated Signatory team; it was edited on 21 September to remove medicine naming. AstraZeneca did not consider the edited post promotional, so it was not certified.
The Sunday Times piece (“Hopes rise for breast cancer cure”) included strong “cure”/“shattered expectations” messaging, named Enhertu, included price information, and quoted a very senior employee about transforming physician–patient discussions and the possibility of a cure.
The Panel assessed press coverage based on what AstraZeneca provided to the journalist (press release and interview), not solely the published article.
Enhertu had a marketing authorisation at the time, but the setting discussed (HER2-positive metastatic breast cancer in the context used) was an unlicensed indication for Enhertu.

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LinkedIn post: Breaches of Clauses 2, 5.1, 8.1, 26.2. No breach of Clauses 3.1 and 26.1.
Sunday Times / press release & interview: Breaches of Clauses 2, 5.1, 6.1, 8.1, 11.2, 26.1, 26.2. No breach of Clauses 3.1 and 11.1.
Undertakings allegation (linked to Alexion cases): Panel considered the current case sufficiently different; no breach found in relation to undertakings as alleged.
No appeal.

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