Novartis breached ABPI Code over Kisqali leaflet: unclear combination partner and outdated survival-data footnote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
Complainant	Anonymous (described him/herself as a health professional)
Company	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 (meeting held 4 October 2019)
Main issues	Ambiguity about applicability of OS data to different combination partners (AI vs fulvestrant; AI vs tamoxifen) and an inaccurate footnote about MONALEESA-3 OS data availability
Breach clauses	7.2, 7.4, 9.1
No breach clauses	2, 3.2
Sanctions	Undertaking received; additional sanctions not stated
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
Applicable Code year	2019

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

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What happened

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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 on 4 October 2019.
The leaflet focused on overall survival (OS) results from MONALEESA-7 in pre/peri-menopausal patients, where endocrine partners were goserelin plus either tamoxifen or a non-steroidal aromatase inhibitor (NSAI); no patients received fulvestrant.
Headline claim: “First-line Kisqali. The difference for patients is survival.” The Panel considered “first-line Kisqali” could be read as Kisqali with either an aromatase inhibitor or fulvestrant (both indicated for initial endocrine-based therapy), implying the OS data applied to both combinations.
Prominent claim: “Kisqali is the only CDK4/6 inhibitor to demonstrate significant overall survival benefit from a first-line phase III trial in a placebo-controlled trial of premenopausal women in combination with endocrine treatment as initial therapy”. The Panel did not find the “only” claim misleading on the evidence provided, but found the leaflet did not clearly state the claims related to the aromatase inhibitor combination (and not tamoxifen), creating a misleading implication.
A footnote stated: “[Overall survival] Data from MONALEESA – 2 and MONALEESA – 3 phase III trials in postmenopausal women with HR+/HER2 – advanced breast cancer are not available yet”. OS data from MONALEESA-3 had been released publicly at ESMO five days before the meeting, so the statement was inaccurate at the time of use.
On appeal, the Appeal Board was concerned that Novartis did not know the leaflet had been used at the meeting until the PMCPA complaint, and considered the leaflet should have been withdrawn and/or amended once the new data were published.

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Outcome

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Breach found: the leaflet was misleading due to lack of clarity that MONALEESA-7 OS data related only to Kisqali with an aromatase inhibitor (not fulvestrant) and due to an inaccurate “data not available yet” footnote.
No breach found: Clause 3.2 (promotion inconsistent with the SPC) and Clause 2 (particularly serious breach) were not breached on the allegations considered.
Breach found and upheld on appeal: Clause 9.1 (high standards) due to multiple misleading/inaccurate elements and failure to withdraw/amend material in light of new data; the Appeal Board cited poor governance/lack of care.

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Key facts

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