Freedom of Information request on Trastuzumab deruxtecan and oesophageal/gastric cancer (FOI 21/928)
Published 20 January 2022
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25th August 2021
FOI 21/928
Dear,
Thank you for your email of 05 August regarding Trastuzumab deruxtecan and whether it may be approved for treatment of oesophageal/gastric cancer.
The current Summary of Product Characteristics (SmPC) for this medicine confirms, within Section 4.1, the current licensed indication(s) which is as follows:
Therapeutic indications
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.
The approval of any further indications for this or any other medicine would require an application from the licence holder alongside data to demonstrate the safety, quality and efficacy of the medicine for the additional indication.
We neither confirm nor deny that we hold information falling within the description specified in your request. The duty in Section 1(1)(a) of the Freedom of Information Act 2000 does not apply, by virtue of Section 41 (information provided in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act. This should not be taken as an indication that the information you requested is or is not held by us.
Section 41 is an absolute exemption that requires no consideration of the public interest, except to state that we would consider the release of this information to be an actionable breach of confidence. Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in confirming whether an application for a product has been received or not by MHRA, thereby informing competitors of the proximity to market of a particular product.
However, we recommend you contact the licence holder directly to confirm whether they intend to apply for this additional indication for this medicine. Their contact details can be found below:
Daiichi Sankyo UK Ltd
https://www.daiichi-sankyo.co.uk/services/contact-us/
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.
The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
If you have a query about our response then please reply to this email.
Yours sincerely,
Customer Services