Bakgrund

Daiichi Sankyo Nordics Aps (Daiichi) marknadsför Vanflyta (kizartinib), ett antineoplasiskt medel, proteinkinashämmare, och har som pliktexemplar inkommit till IGN med en film angående detta läkemedel (bilaga).

Vanflyta är indicerat i kombination med standardmässig induktionsbehandling med cytarabin och antracyklin och standardmässig konsolideringskemoterapi med cytarabin, följt av underhållsbehandling med VANFLYTA som enda läkemedel för vuxna patienter med nydiagnostiserad akut myeloisk leukemi (AML) som är FLT3-ITD-positiv.
 

Excerpt: Aktualiserad artiklar i ärendet: artikel 4 och artikel 19 (kapitel 1, avdelning 1), Läkemedelsbranschens etiska regelverk (LER).

Anmärkning

IGN har mottagit en film (se skärmbild bilaga 2) angående Vanflyta som pliktexemplar. I filmen påstås efter c:a 45 sekunder: "Vanflyta + standard chemotherapy demonstrated a 22% reduction in the risk of death vs placebo + standard chemotherapy" samt "Vanflyta reduced the risk of relapse or death by 39%"

Enligt gällande praxis får inte riskreduktion och liknande mått anges i enbart relativa termer. Skälet är att läsaren riskerar förmedlas ett överdrivet intryck av studieresultatet och ändamålsenligheten med läkemedlet ifråga. Absoluta tal, eller Number Needed to Treat, ska därför också anges då uppgifterna annars riskerar att bli ovederhäftiga och vilseledande i strid med artikel 4 LER (kapitel 1, avdelning 1).

Minimitexten vid filmens slut visas under så kort tid att texten inte hinner läsas och filmen kan därför strida mot läsbarhetskravet i artikel 19 LER (kapitel 1, avdelning 1).

Svaromål

We refer to IGN’s comments concerning the promotional video for Vanflyta as of 22 June 2026 and set out below our response on behalf of Daiichi Sankyo Nordics’s headquarter, Daiichi Sankyo Europe (“DSE”) to the issues raised regarding the clinical data, the primary endpoint focus, and the minimum text displayed.

We have taken note of IGN’s comments and wish to assist in ensuring a complete and accurate understanding of the factual circumstances surrounding the promotional video at the exhibition stand.

1 Regarding the Clinical Data and Primary Endpoint Focus

The Committee has raised concerns regarding the presentation of the clinical data in the promotional video. It is our position that the clinical data was presented in a balanced, scientifically accurate, and non-misleading manner. Furthermore, all statements presented in the video are derived directly from, and are fully consistent with, the approved SmPC and the QuANTUM-First study.

1.1 Primary Endpoint Focus

As expressly set out in Section 5.1 of the approved SmPC (attached as Appendix 1), the primary efficacy endpoint was overall survival (OS). The promotional video focuses exclusively on this approved primary endpoint and presents the corresponding efficacy data in a manner that is fully consistent with the approved SmPC.

1.2 Significant Efficacy

The promotional video presents the approved efficacy data demonstrating that quizartinib/kizartinib, in combination with standard chemotherapy, significantly improved overall survival compared with placebo in combination with standard chemotherapy, corresponding to a 22% reduction in the risk of death (hazard ratio [HR] vs placebo: 0.776; 95% CI: 0.615–0.979). These data are presented as approved in the SmPC and accurately reflect the exact efficacy results.

1.3 Context of Secondary Endpoints

The 39% reduction in the risk of relapse or death presented in the promotional video is a clinical finding from the peer-reviewed publication of the QuANTUM First study (attached as Appendix 2, with the relevant passage highlighted on page 9). This forms part of the broader clinical evidence base supporting the efficacy profile of quizartinib/kizartinib. We acknowledge that, in accordance with Section 5.1 of the SmPC, the primary efficacy endpoint is overall survival (OS).

However, the referenced 39% reduction relates to a secondary efficacy endpoint assessed in the QuANTUM-First study. This figure corresponds to the event-free survival (EFS) analysis, which was included in the promotional video to provide a comprehensive and descriptive overview of the clinical trial results, consistent with established practice in the communication of clinical data.

We maintain that the inclusion of this information is fully aligned with the clinical evidence from the trial and does not conflict with the primary endpoint as defined in the SmPC.

Any references to secondary or exploratory endpoints in the promotional video were presented in the context of the statistically significant primary endpoint of overall survival. This was intended to ensure that the target audience was not misled and to support a balanced communication of the core clinical profile of the medicinal product, as defined in the approved SmPC.

1.4 Conclusion

We fully acknowledge the importance of ensuring that information is presented in a clear, balanced, and non-misleading manner. The relative risk reductions of 22% (overall survival) and 39% (event-free survival) were featured because they represent the statistically significant hazard ratios directly derived from the SmPC and the peer-reviewed publication of the QuANTUM-First study. As shown in the attached publication excerpt, the 39% reduction corresponds precisely to a hazard ratio of 0.61. Our intention was to accurately reflect the primary and key secondary efficacy findings as approved and published.

In light of the above, we respectfully request that IGN reconsider its assessment of the presentation of the clinical data and endpoints in the promotional video.

2 Regarding the Minimum Text

The Committee has expressed concerns that the minimum text displayed at the end of the promotional video was shown for such a short duration that it may not comply with Article 19, Chapter 1, Section 1 of the LER.

2.1 Interpretation of Article 19, 1, Section 1 of the LER

In our view, the assessment under Article 19 of the LER should be conducted in light with the overall manner in which the information was made available to the target audience.

This interpretation is supported by the IGN’s own guidance on minimum information/mandatory text in relation to roll-ups and banners, in which the IGN states:

“It depends on the overall impression of all the information in the exhibition stand. The basic rule is that minimum information should be on a roll-up/banner. In a manned stand, however, the minimum information does not have to be printed on a roll-up/banner, but it can be available in the stand, in printed or digital form. There must be a clear indication in a roll-up/banner or, for example, in a note/sign in the stand about where the minimum information is available.”

(attached as Appendix 3)

In our view, this guidance reflects a general principle that applies by analogy to a video screen at an exhibition stand. Roll-ups, banners and video screens serve the same function in the context of an exhibition stand. All tools are visual communication tools intended to attract attention and support the overall messaging at the exhibition stand. We find no legal basis for treating a video screen more strictly than a roll-up or banner in this regard, where both form part of the same staffed exhibition stand and do not operate as standalone advertisements outside their contextual setting.

Further, in the context of a staffed exhibition stand, minimum information does not necessarily need to be reproduced on each individual communication element, provided that the information is available elsewhere at the exhibition stand and that the overall presentation ensures clear access for the recipient.

Finally, the objective of the requirement for minimum information is to ensure that recipients are provided with the information necessary to assess the advertising message on a sound and balanced basis. This objective is fulfilled where the information at a staffed exhibition stand is clearly accessible in printed or digital form, and where the stand clearly indicates where such information can be found.

2.2 The Minimum Text Available in the Exhibition stand

In the present case, the video screen did not constitute an isolated or standalone advertising unit but rather formed an integral part of a staffed exhibition stand. The mandatory text was visible upon entering the exhibition stand and was also displayed at several locations within the exhibition stand (pictures attached as Appendix 4). The overall layout of the exhibition stand was specifically designed to ensure immediate access to the mandatory information. A large, static, and fully legible panel containing the minimum text was prominently integrated into the exhibition stand architecture directly to the right of the main video screen. Furthermore, physical brochures containing the minimum text were readily available in the kiosk positioned in the immediate foreground, directly in the viewer's line of sight when looking at the screen.

The decisive factor should not be whether the mandatory text on the promotional video screen could be fully read within the time it was displayed in the video sequence. Rather, the decisive factor should be whether the recipients exposed to the exhibition stand had genuine and sufficient access to the minimum information, based on the stand’s overall layout and informational materials.

It should also be given weight that the exhibition stand was staffed with trained employees. The guidance expressly distinguishes between roll-ups/banners and staffed exhibition stands and accepts that minimum information in staffed stands may be provided in printed or digital form. That distinction is directly relevant to the present case.

In DSE’s staffed exhibition stand, the visitors could obtain further information, ask questions, and be directed to the relevant minimum information. The exhibition stand included the mandatory text displayed in multiple locations and was designed to provide immediate access to the SmPC.

This reduces any risk that the recipient relies solely on a single communication element, such as a video screen. The assessment should therefore be based on the exhibition stand’s overall information environment, rather than an isolated evaluation of the video screen.

2.3 Conclusion

We fully acknowledge the importance of ensuring that mandatory text is easily legible and that the text displayed in the promotional video alone is not sufficient in itself.

However, we respectfully request that IGN reconsider its assessment of the minimum text in the video in the specific context, in light of the concurrent and clearly visible placement of the mandatory text at the exhibition stand.

If IGN maintains its view that the requirements are not met, we would be grateful for further clarification in that respect. We remain, of course, at IGN’s disposal to provide any further information or otherwise assist as needed.

IGNs bedömning och beslut

I sitt svaromål kommenterar inte Daiichi det som anmärkningen beträffande artikel 4 gällde, att när effektdata redovisas i enbart relativa termer så riskerar framställningen att bli vilseledande om den inte kompletteras med uppgifter om absoluta tal (eller number needed to treat).  Detta följer av omfattande praxis, se till exempel NBL 1033/16.

Beträffande minimitexten så accepterar IGN Daiichis svaromål att då denna fanns tillgänglig i direkt anslutning till där filmen visades så är regelverkets krav uppfyllda.

IGN bedömer således, med hänvisning till ovan sagda, att filmen inte uppfyller kraven i artikel 4 LER (kapitel 1, avdelning 1), då effekten av läkemedlet uttryckts endast i relativa termer.

Avsteget bedöms vara en överträdelse av normalgraden och därför bestäms avgiften till 110 000 kr. Fakturering sker från LIF Service AB.

Daiichi uppmanas att framdeles vid utformningen av sin läkemedelsinformation beakta vad IGN här har anfört.

Detta yttrande har avgivits av ordförande Anders Öhlén, ledamöterna Björn Isaksson och Margareta Olsson Birgersson. I ärendets beredning har också medverkat suppleanterna Annika Ohlsson och Hans Siltberg.

 

På informationsgranskningsnämndens vägnar

Anders Öhlén

 

Bilaga 1: Fullständigt svaromål med samtliga appendices.

Bilaga 2: Skärmbild film