Ipsen found in breach for Cabometyx meeting discussion that advocated a lower starting dose (AUTH/3103/10/18)

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Key facts

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Case number	AUTH/3103/10/18
Complainant	Anonymous, non-contactable
Company	Ipsen
Medicine	Cabometyx (cabozantinib)
Therapy area	Advanced renal cell carcinoma (RCC)
Issue	Speaker comment interpreted as advocating a 40mg starting dose for “older and smaller patients”, inconsistent with SPC
Complaint received	03 October 2018
Case completed	06 December 2018
Applicable Code year	2016
Appeal	No appeal
Outcome	Breach of Clause 3.2; no breach of Clauses 2, 7.2, 7.4, 7.9, 9.1, 12.1
Sanction	Undertaking received

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

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An anonymous, non-contactable complainant alleged an Ipsen meeting about Cabometyx (cabozantinib) for advanced renal cell carcinoma (RCC) was a “glorified sales pitch”, biased, and scientifically questionable.
Allegations included: Cabometyx was promoted as a “new gold standard”; competitor side effects were emphasised; pazopanib (Votrient) was omitted; Ipsen focused on sunitinib (Sutent) to publicise Phase II data; and “real-world evidence” was presented as a handful of case studies.
The meeting materials repeatedly stated it was promotional, organised and funded by Ipsen, and included prescribing information.
During a panel discussion, in response to an unprompted question about starting dose, one speaker said they often started “older and smaller patients” on 40mg and then adjusted up/down.
The Cabometyx SPC recommended a starting dose of 60mg once daily; it did not recommend dose adjustment based on age (≥65) or weight.

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No breach found for Clauses 2, 7.2, 7.4, 7.9, 9.1 and 12.1.
Breach found for Clause 3.2 because the speaker’s comment was considered to advocate a lower starting dose inconsistent with the SPC.
The Panel reiterated the principle that companies are responsible for what contracted speakers say on their behalf.

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