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BRIEF-ARIAD announces FDA full approval and label update for Iclusig (ponatinib)
2016年11月29日 / 下午3点27分 / 1 年前

BRIEF-ARIAD announces FDA full approval and label update for Iclusig (ponatinib)

Nov 29 (Reuters) - ARIAD Pharmaceuticals Inc :

* ARIAD announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial

* ARIAD announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial

* New label update for CP-CML reflects 55 percent MCyR, and 39 percent MMR, a key secondary endpoint deeper than cytogenetic response

* ARIAD expects initial data from optic trial to be submitted to American Society of Hematology (ASH) meeting in 2017

* Safety and efficacy profile for Iclusig updated based on 48-month follow-up Source text for Eikon: Further company coverage:

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