Withdrawal of the marketing authorisation from EMA of Jivadco (trastuzumab duocarmazine) for the treatment of HER2-positive breast cancer. Medac GmbH
Medac Gesellschaft für klinische Spezialpräparate mbH withdrew its application for a marketing authorisation of Jivadco (trastuzumab duocarmazine) for the treatment of HER2-positive breast cancer.
The company withdrew the application on 12 September 2023. Based on the review of the data and the company’s response to the Agency’s questions, at the time of the withdrawal, the Agency had some significant concerns and its provisional opinion was that Jivadco could not have been authorised for the treatment of HER2-positive breast cancer. EMA’s human medicines committee (CHMP) had concerns about the way the company analysed the data on progression-free survival, which made it difficult to determine how well the medicine works. The analysis did not adequately address patients who stopped treatment, and patients were not followed up adequately. In addition, an inspection of the clinical trial sites revealed some findings that could affect the reliability of the results. Therefore, at the time of the withdrawal, the Agency’s opinion was that the benefits of Jivadco did not outweigh its risks.
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