ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced adoption of a positive opinion by the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) on the continued availability of Iclusig ® (ponatinib) in the EU for use in patients in its authorized indications. Following its review of updated clinical-trial data on Iclusig, the CHMP made a series of recommendations on measures to help minimize the risk of occlusive vascular events in patients taking Iclusig. The authorized indications of Iclusig, as approved in July 2013, are as follows:
- The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
- The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
The EMA has recommended the following:
- Iclusig should not be used in patients with a history of heart attack or stroke, unless the potential benefits of treatment outweigh the risks.
- The cardiovascular status of patients should be assessed and cardiovascular risk factors actively managed before starting treatment with Iclusig. Cardiovascular status should continue to be monitored and optimised during treatment.
- Hypertension should be controlled during treatment with Iclusig, and healthcare professionals should consider interrupting treatment if hypertension is not controlled.
- Patients should be monitored for evidence of vascular occlusion or thromboembolism, and treatment should be interrupted immediately if this occurs.
The EMA plans to conduct a further review of the benefits and risks of Iclusig and may make additional recommendations on how Iclusig should be used.