Janssen: Imbruvica leaflet strapline ‘Destination survival’ ruled misleading across multiple indications (AUTH/3128/12/18)

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Key facts

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Case	AUTH/3128/12/18
Company	Janssen-Cilag Limited
Product	Imbruvica (ibrutinib)
Material	Leaflet “Getting started with once-daily, oral, single-agent Imbruvica (ibrutinib)” (ref PHGB/IBR/0616/0007(9))
Setting	Exhibition stand at UK Oncology Nurses Society meeting, Glasgow (November 2018)
Main issue	Strapline “Destination survival” considered an OS-type claim; leaflet referenced multiple indications but evidence did not support the claim across all indications
Applicable Code year	2016
Complaint received	02 December 2018
Case completed	12 July 2019
Appeal	No appeal
Breach clauses	7.2, 7.4, 9.1
No breach clause(s)	7.2 (absence of survival data in the leaflet)
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An individual complained about a leaflet promoting Imbruvica (ibrutinib) on Janssen-Cilag’s exhibition stand at a UK Oncology Nurses Society meeting in Glasgow (November 2018).
The leaflet (ref PHGB/IBR/0616/0007(9)) was titled “Getting started with once-daily, oral, single-agent Imbruvica (ibrutinib)”.
The Imbruvica logo appeared on multiple pages with the strapline “Destination survival”, alongside space-travel imagery.
The leaflet listed all Imbruvica indications (including CLL, relapsed/refractory MCL and WM) and contained administration/safety information but no efficacy or survival data.
The complainant alleged the strapline was misleading, implying an overall survival (OS) benefit when there was none, and also objected to the absence of survival data in the leaflet.
Janssen argued the strapline was supported by OS data in CLL (SPC Section 5.1; Burger et al 2015; Byrd et al 2014) and provided additional data for other indications when requested.

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Breach upheld: Clauses 7.2, 7.4 and 9.1.
No breach: Clause 7.2 (in relation to the specific allegation that the claim was misleading solely because the leaflet did not include survival data).
The Panel considered oncology health professionals would, on the balance of probabilities, associate “Destination survival” with an overall survival benefit.
The Panel found that because the leaflet featured all indications, but not all indications had a body of evidence supporting an OS-type claim, the strapline was misleading and not capable of substantiation in that context.

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