AUTH/3534/7/21: Astellas v Janssen — Zytiga “Quality of Life” webpage (misleading comparisons and incomplete context) | PMCPA Case

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Key facts

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Case	AUTH/3534/7/21
Complainant	Astellas Pharma Limited
Respondent	Janssen
Product	Zytiga (abiraterone acetate)
Medium	Webpage on Janssen Medical Cloud (“Zytiga Quality of Life”)
Therapy area / indication discussed	mCRPC (metastatic castrate-resistant prostate cancer)
Comparators referenced	Enzalutamide (Xtandi) and placebo (as presented in different studies)
Complaint received	07 July 2021
Case completed	01 December 2022
Applicable Code	2019
Appeal	No appeal
No breach clauses (as listed)	7.2 7.3 7.8
Breach clauses (as listed)	7.2 7.3 7.8 7.9 8.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Astellas complained about a Janssen Medical Cloud webpage titled “Zytiga Quality of Life” promoting Zytiga (abiraterone acetate) in mCRPC.
The page presented multiple QoL/HRQoL claims and charts adapted from three studies (including comparisons vs enzalutamide and vs placebo).
Key issues included: (a) whether broad HRQoL improvement claims were substantiated, (b) whether fatigue/cognitive claims were presented clearly with correct context, and (c) whether PHQ-9 content implied an adverse effect (depression) for enzalutamide in a misleading/disparaging way.
Inter-company dialogue occurred; some wording/dose issues were amended during dialogue (the Panel made no ruling on Clause 3.2 as that matter was considered settled in dialogue).

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No breach for the main headline claim: “ZYTIGA COULD SIGNIFICANTLY IMPROVE HRQoL…”, as Astellas did not prove it was misleading on the narrow allegation made (no breach of Clause 7.2 for that point).
Breach where fatigue chart sample sizes were unclear (numbers shown looked like questionnaire completers but were original sample sizes), making the presentation misleading (Clause 7.2).
Breach for omitting that certain PRO data were derived from exploratory endpoints, meaning the claim was not sufficiently complete (Clause 7.2).
Breach where two bar charts placed under an overarching fatigue-vs-enzalutamide heading created the impression both supported the enzalutamide comparison, compounded by using the same colour for different comparators (enzalutamide and placebo) (Clauses 7.3 and 7.8).
Breach where the corrected “hypothesis generating” caveat (post-hoc / not prespecified) was not sufficiently clear to enable an informed comparison (Clause 7.3).
Breach for PHQ-9 content implying unfavourable depression-related data for enzalutamide vs abiraterone in a way that did not reflect available evidence and disparaged the comparator (Clauses 7.3, 7.9 and 8.1).
No appeal.

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