The European Medicines Agency (EMA) has confirmed an ongoing shortage of ifosfamide‑containing cancer medicines across all EU and European Economic Area (EEA) member states, with supply constraints expected to last until the first quarter of 2027. The products, marketed by Baxter under the Holoxan brand and other trade names such as Tronoxal and Mitoxana, are used to treat multiple tumor types including sarcoma, lymphoma, testicular, lung and ovarian cancers.
According to EMA, the shortage stems from a technical problem at the manufacturing site, compounded by site improvements required following a regulatory inspection in September 2025, which caused a pause in production and product release. Manufacturing has since resumed, but the temporary halt has created a supply gap that will take several years to resolve as the facility ramps back up to full capacity. EMA stressed that the issue is not linked to a product quality defect or safety concern.
The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products and its shortages working party are closely monitoring supply and engaging with Baxter, alternative manufacturers and international regulators. EMA advises clinicians to ensure adequate stock before starting ifosfamide treatment and, where necessary, to consider alternative therapies in line with clinical guidelines.
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