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Trastuzumab emtansine (Kadcyla°) in certain breast cancers, after neoadjuvant treatment with trastuzumab + chemotherapy and surgery

Marketing Authorisations Trastuzumab emtansine (Kadcyla°) has been authorised in the European Union since 2019 for use as monotherapy after surgery in women or men with breast cancer overexpressing HER2 who have residual invasive disease despite treatment with a combination of chemotherapy + HER2-targeted therapy before surgery. This marketing authorisation was based on data from an interim analysis of a non-blinded randomised trial. In light of current data, does trastuzumab emtansine compared with trastuzumab extend survival in this situation? Does it have fewer or milder adverse effects?
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EDITORS' OPINION
New data

The data underpinning a drug's marketing authorisation are frequently sparse or incomplete. In some cases, the only data available are results from a non-comparative trial, or interim results from a single comparative trial whose "final" results are not expected until later. Hence the need to regularly search for new evaluation data on the efficacy and adverse effects of drugs after their market introduction...

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©Prescrire 1 March 2026

Source: "Trastuzumab emtansine (Kadcyla°) in certain breast cancers, after neoadjuvant treatment with trastuzumab + chemotherapy and surgery" Prescrire Int 2026; 35 (279): 67-68. Subscribers only.

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