European Medicines Agency Press Release: Ponatinib

Iclusig is authorised for use in patients with chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL) who cannot take or tolerate several other medicines of the same class (known as ‘tyrosine-kinase inhibitors’). The review followed a previous assessment of clinical trial data which indicated that cases of blood clots and blockages in the arteries or veins were occurring at a higher rate than was observed at the time of the medicine’s initial authorisation.

The available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be dose-related, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment. Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day. The product information will be updated with strengthened warnings about the risks with Iclusig, and to also provide healthcare professionals with the latest evidence in case they wish to consider reducing the dose of Iclusig in patients with ‘chronic phase’ CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage. Additionally, healthcare professionals should stop Iclusig if a complete response has not occurred within three months of treatment, and should monitor patients for high blood pressure or signs of heart problems.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2...