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Ariad’s Leukemia Drug Iclusig Sails Through FDA In Less Than 3 Months

Executive Summary

Ponatinib received accelerated approval for use in chronic myeloid leukemia and acute lymphoblastic leukemia patients who are resistant or intolerant to prior therapy with tyrosine kinase inhibitors.

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In allowing ponatinib back on the market, FDA is requiring the sponsor to address a gap in the original development program – failure to identify the optimal dose. However, Ariad is also looking at the post-marketing requirements as a step in the pathway to use in earlier treatment settings.

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FDA approves new labeling that narrows the indication for Ariad’s leukemia drug to largely the third-line and later setting.

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