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Aug 12, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

AP26113 regulatory update

Ariad disclosed on a conference call to discuss its 2Q13 earnings that FDA denied breakthrough therapy designation for the company's AP26113 for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). According to the company, FDA did not grant the designation because of the "relatively short follow-up" and the small number of ALK-positive patients. Ariad submitted to FDA data from 24 evaluable patients in the...

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