Ariad gets positive CHMP opinion for continued Iclusig availability
The CHMP renders a positive opinion on the continued availability of Ariad's (ARIA) Iclusig for "authorized indications" (various phases of dasatinib or nilotinib-resistant CML, dasatinib-resistant Ph+ ALL, etc.)
The EMA has also made a few recommendations regarding how to cut down on the risk of occlusive vascular events.Suggestions include:
*The drug should not be used by patients with a history of heart attack or stroke,
*patients' cardiovascular status should be assessed prior to treatment,
*hypertension should be controlled over the course of Iclusig treatment,
and
*monitoring should be in place to detect vascular occlusion or thromboembolism.
Strong>Press release 22/11/2013
European Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a number of recommendations to help minimise the risk of blood clots obstructing arteries or veins in patients taking the leukaemia medicine Iclusig.
The CHMP recommends that Iclusig should not be used in patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks. In addition, the cardiovascular risks of all patients should be assessed and measures should be taken to reduce risks before starting and during treatment with Iclusig. Patients who have high blood pressure should have their blood pressure controlled, and treatment with Iclusig should be stopped immediately in any patient with signs of blood clots obstructing arteries or veins. Further details on
see full press release on Home page.