GSK press release on dostarlimab EAMS found promotional to the public and for an unlicensed indication (AUTH/3803/07/23)

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Key facts

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Case	AUTH/3803/07/23
Company	GSK
Complaint	Press release alleged to promote dostarlimab (Jemperli) EAMS scientific opinion to the public and for an unlicensed indication
Medicine	Jemperli (dostarlimab)
Channel	Press release distributed to medical/trade media and mainstream national media
Key issue	Promotional content and broad dissemination, including consumer press, for an EAMS/unlicensed indication
Applicable Code year	2021
Complaint received	26 July 2023
Case completed	06 December 2024
Appeal	No appeal
Breach clauses	Clause 5.1; Clause 11.2; Clause 26.1; Clause 26.2
No breach clauses	Clause 3.1; Clause 11.1
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous complainant alleged GSK promoted Jemperli (dostarlimab) via a press release about an MHRA Early Access to Medicines Scheme (EAMS) positive scientific opinion for endometrial cancer.
The complainant said the medicine did not have a marketing authorisation for the oncology indication described and that the communications were aimed at the public to prompt patients to ask doctors to prescribe it.
The underlying press release (labelled “For media and investors only”) was distributed to >25 medical/trade outlets and also to mainstream national media (including Press Association, Daily Mail, Mail on Sunday, Express, Mirror, Times, Telegraph, The Sun and Evening Standard).
The press release used strong, positive/emotive language, including: “Dostarlimab represents the first treatment breakthrough in this setting of endometrial cancer since 1990” and “patients don’t have time to wait”, plus a commercial quote that “dostarlimab plus chemotherapy could represent the first meaningful frontline treatment advancement in decades”.
GSK said it believed an EAMS announcement could be newsworthy, but accepted the execution was “suboptimal”, the audience was too broad, and the wording could be perceived as creating urgency.
The press release was developed with an external agency, approved via GSK’s UK approval system by a registered pharmacist signatory, and shared with the MHRA before release.

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Breach of Clause 5.1 Failing to maintain high standards.
Breach of Clause 11.2 Promoting a medicine for an unlicensed indication.
Breach of Clause 26.1 Promoting a prescription only medicine to the public.
Breach of Clause 26.2 Providing unbalanced information and encouraging members of the public to ask for a specific prescription only medicine.
No Breach of Clause 3.1 Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation.
No Breach of Clause 11.1 Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation.

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