Novartis breached ABPI Code over Kisqali leaflet: unclear combination partner and outdated survival-data footnote

📊

Key facts

⌄

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 (delegate bag), October 2019
Main issues upheld	Lack of clarity that OS data/claims related only to Kisqali + aromatase inhibitor (not fulvestrant; and misleading implication re tamoxifen); inaccurate footnote stating MONALEESA-3 OS data “not available yet” when it was public
Applicable Code year	2019
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; unsuccessful

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

🎬 Expert Video Walkthrough

🎬

Video walkthrough — coming for members

Subscribe now and get expert video analysis for every case as we publish them.

Subscribe — from £299/yr

📋

⌄

An anonymous health professional complained about a Novartis promotional leaflet for Kisqali (ribociclib succinate) (ref KIS19-CO25a), dated June 2019.
The leaflet was placed in delegate bags at a breast cancer meeting held in 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” positioning and endocrine therapy combinations.
The PMCPA asked Novartis to consider Clauses 2, 3.2, 7.2, 7.4 and 9.1 (Code year 2019).

⚖️

⌄

Breach: Clause 7.2 (misleading) – OS messaging implied applicability to combinations not supported by the cited dataset (including lack of clarity re aromatase inhibitor vs fulvestrant; and implication re tamoxifen).
Breach: Clause 7.4 (substantiation) – where claims/statement could not be substantiated (including the inaccurate “data not available yet” footnote; and lack of clarity re fulvestrant).
Breach: Clause 9.1 (high standards) – upheld by the Appeal Board, citing multiple breaches and failure to withdraw/amend material after new data became public.
No breach: Clause 3.2 (promotion consistent with SPC) – Panel did not find the leaflet inconsistent with the SPC overall, despite clarity issues.
No breach: Clause 2 – Panel did not consider the circumstances warranted this “particular censure”.
Novartis appealed only the Clause 9.1 ruling; the appeal was unsuccessful.

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access