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

This article was originally published in The Pink Sheet Daily

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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Ariad’s Iclusig Clinical Program Held Up By Mounting Cardio Events

FDA issued a partial clinical hold due to the growing number of cardiovascular events in the pivotal PACE trial, which had been ongoing after ponatinib won accelerated approval based on response rate in December 2012.

Ariad Unfazed By FDA Breakthrough Denial

FDA denied a “breakthrough” designation request for ALK/EGFR inhibitor AP26113, but the door is open for another try, and the undaunted company is launching a pivotal trial in NSCLC this quarter. Ariad also reported a continued successful launch of its leukemia drug Iclusig.

Ariad Unfazed By FDA Breakthrough Denial

FDA denied a “breakthrough” designation request for ALK/EGFR inhibitor AP26113, but the door is open for another try, and the undaunted company is launching a pivotal trial in NSCLC this quarter. Ariad also reported a continued successful launch of its leukemia drug Iclusig.

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