Roche: Rozlytrek dosing webpage omitted key SPC dose-modification guidance (AUTH/3646/5/22)

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Key facts

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Case	AUTH/3646/5/22
Parties	Complainant v Roche
Medicine	Rozlytrek (entrectinib)
Material/channel	Roche Resources promotional website dosing webpage (HCP-gated); “Dosing” page with “Suggested Monitoring” section
Key issue	Omission of important SPC dose-modification/discontinuation information, creating misleading impression of completeness on a dosing-dedicated page
Clinical areas referenced	Heart (CHF/QT prolongation), Liver (ALT/AST elevations), CNS adverse reactions, Blood (hyperuricaemia, anaemia, neutropenia), Bones (fractures)
Black triangle	Yes (noted by Panel)
Applicable Code	2021
Complaint received	12 May 2022
Case completed	23 May 2023
Appeal	No appeal
Breach clauses	Clause 6.1; Clause 5.1; Clause 2
No breach clauses	Clause 6.1; Clause 6.2
Sanctions	Undertaking received; Advertisement

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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 Roche’s HCP-gated Roche Resources promotional webpage for Rozlytrek (entrectinib) focused on dosing considerations (material code M-GB-00004833; date of preparation November 2021).
The webpage included a “Suggested Monitoring” section (Heart, Liver, CNS, Blood, Bones) but, according to the complaint, did not include the specific SPC Table 4 criteria for when to withhold, reduce dose, resume, or discontinue treatment.
Omissions alleged to create patient safety risk, particularly given Rozlytrek is a black triangle medicine (additional monitoring).
Roche argued the page referenced the SPC, included multiple links to prescribing information, and that HCPs would consult the SPC before prescribing.
The Panel considered the overall impression to a busy health professional and whether the dosing webpage could “stand alone” under the Code.

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Outcome

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Breach of Clause 6.1 (misleading) because the dosing webpage gave the misleading impression it contained all important dosing/monitoring information, while omitting key SPC dose-modification/discontinuation instructions for: congestive heart failure/QT prolongation, elevated ALT/AST, CNS adverse reactions, and hyperuricaemia/anaemia/neutropenia.
No breach of Clause 6.2 (substantiation) because there was no allegation that the information was not capable of substantiation.
No breach</strong of Clause 6.1 and Clause 6.2 in relation to fractures/bones (the complainant did not establish misleadingness or lack of substantiation for that section).
Breach of Clause 5.1 (high standards) given omissions of important safety information for a black triangle product on a dosing-dedicated page.
Breach of Clause 2 (discredit/reduced confidence) because omission of important safety information risked prejudicing patient safety.
No appeal.

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Clauses
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Breach of Clause 6.1 Providing misleading information
Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
No Breach of Clause 6.1 Requirement that information must not be misleading
No Breach of Clause 6.2 Requirement that information must be capable of substantiation

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Key facts

What happened

Outcome

Clauses

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