Ariad Pharmaceuticals Inc fka ARIA

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>> PRAC's decision clearly puts what was wrong with FDA's action.

How? Do you understand PRAC's decision? It is almost identical to what FDA's current label for Iclusig. As of risk/reward, it is for certain narrow population. EMA/PRAC never recommended broad 2nd line label as FDA did originally but took away later on.

Here is FDA label:

2.1 DOSAGE AND ADMINISTRATION

Recommended Dosing The optimal dose of Iclusig has not been identified. In clinical trials, the starting dose of Iclusig was 45 mg administered orally once daily. However, 59% of the patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy. Start dosing with 45 mg once daily. Consider reducing the dose of Iclusig for CP CML and AP CML patients who have achieved a major cytogenetic response. Consider discontinuing Iclusig if response has not occurred by 3 months (90 days). Iclusig may be taken with or without food. Tablets should be swallowed whole.

Here is PRAC recommendation:

The PRAC therefore considered that the recommended starting dose of Iclusig should remain 45 mg once a day. However, updates to the product information are recommended to provide healthcare professionals with the latest evidence, in case they wish to consider reducing the dose in patients with ‘chronic phase’ CML who are responding well to treatment, and who might be at particular risk of blood vessel blockage. In addition, healthcare professionals should stop Iclusig if there has been no response after three months of treatment, and monitor patients for high blood pressure or signs of heart problems.