Novartis breached ABPI Code over Kisqali leaflet: unclear combination partner and outdated survival-data footnote

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Key facts

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Case	AUTH/3256/10/19
Parties	Anonymous complainant v Novartis Pharmaceuticals UK Ltd
Product	Kisqali (ribociclib succinate)
Material	Promotional leaflet (ref KIS19-CO25a), dated June 2019
Where used	Breast cancer meeting/conference; leaflet in delegate bag (used 4 October 2019)
Main issues upheld	Ambiguity about which combination partner the OS data applied to (aromatase inhibitor vs fulvestrant/tamoxifen) and an inaccurate footnote stating MONALEESA-3 OS data was not available
Breach clauses	7.2, 7.4, 9.1
No breach clauses	2, 3.2
Applicable Code year	2019
Complaint received	3 October 2019 (PDF) / 08 October 2019 (website listing)
Case completed	4 August 2020
Appeal	Appeal by respondent (Novartis) against Clause 9.1 ruling; unsuccessful
Sanctions	Undertaking received; additional sanctions not stated

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

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An anonymous health professional complained about a Novartis promotional leaflet for Kisqali (ribociclib succinate) (ref KIS19-CO25a), dated June 2019, placed in delegate bags at a breast cancer meeting (used 4 October 2019).
The leaflet focused on overall survival (OS) data from MONALEESA-7 in pre/peri-menopausal patients.
The complainant alleged the leaflet was misleading/inaccurate and implied off-label use, including around “first-line” messaging and endocrine therapy combinations.
The Panel found the leaflet did not clearly state that the OS data being promoted related to Kisqali in combination with a non-steroidal aromatase inhibitor (and not fulvestrant), creating a misleading implication.
The Panel also found the leaflet did not clearly state that certain claims were only in relation to the aromatase inhibitor combination (and not tamoxifen), creating a misleading implication.
A footnote stated OS data from MONALEESA-2 and MONALEESA-3 were “not available yet”; by the time the leaflet was used, MONALEESA-3 OS data was publicly available, making the statement inaccurate.
Novartis appealed the finding that these issues amounted to a failure to maintain high standards; the Appeal Board upheld the breach and criticised governance, including failure to withdraw/amend the leaflet after new data became public.

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Breach found: Clauses 7.2 and 7.4 (misleading claims / substantiation) in relation to lack of clarity about applicable combination partner(s) and an inaccurate “data not available yet” footnote.
Breach found: Clause 7.2 (misleading) in relation to implication that data applied to combination with tamoxifen.
Breach found (upheld on appeal): Clause 9.1 (high standards not maintained).
No breach: Clause 2 (not a case for particular censure).
No breach: Clause 3.2 (promotion inconsistent with the SPC) on the narrow allegations considered.
One prominent “only CDK4/6 inhibitor…” claim was ruled not misleading / not incapable of substantiation (no breach of Clauses 7.2 and 7.4 for that aspect), but the leaflet still breached Clause 7.2 due to lack of clarity about tamoxifen vs aromatase inhibitor.

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