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EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.
The European Medicines Agency (EMA) has recommended the marketing authorization of a first-in-class medicine, Trodelvy (sacitusumab govitecan), to treat patients with an aggressive form of breast cancer.
More specifically, it was revealed in an Oct. 15, 2021 press release that the recommendation is for Trodelvy to be used in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have already received two or more systemic therapies, with at least one of those treatments being for advanced disease. As patients with this aggressive form of breast cancer tend to be unresponsive to the standard treatment, chemotherapy, there is a high unmet medical need for new treatments in this area to improve patients’ outcomes.
Trodelvy combines a humanized antibody with a type of an antineoplastic agent called topoisomerase I inhibitor, which are intended to inhibit cancer growth, division, and spread. The marketing authorization application for the treatment has been evaluated under an accelerated process in efforts to speed up patient access to the medicine.
The regulatory authority’s recommendation was based on the data from a Phase III clinical trial that evaluated the safety and efficacy of Trodelvy in 529 patients. In the trial, it was found that the therapy helped to prolong the overall survival of patients by approximately five months and progression-free survival by approximately three months.
This recommendation will now be sent to the European Commission for a final decision on marketing authorization for the European Union. If a positive final decision is made, each European member state will make decisions on price and reimbursements for the medicine