BioCentury
ARTICLE | Company News

FDA denies breakthrough for Ariad's AP26113

August 7, 2013 11:38 PM UTC

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) disclosed on a conference call to discuss its 2Q13 earnings on Wednesday 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 Phase I portion of a Phase I/II trial, where AP26113 led to 14 partial responses, including 12 in patients resistant to Xalkori crizotinib from Pfizer Inc. (NYSE:PFE), and one complete response in a Xalkori-naive patient. AP26113 is a small molecule dual inhibitor of ALK and EGFR. Ariad said it can resubmit an application for the designation, but the company is not commenting on whether or when it would resubmit. The company plans to present updated data from the trial in September.

Earlier this year, FDA granted breakthrough designation to LDK378 from Novartis AG (NYSE:NVS; SIX:NOVN) to treat ALK-positive metastatic NSCLC in patients who have progressed on or who are intolerant to Xalkori. The designation was based on initial results from a Phase I trial that included an 80% response rate among ALK-positive NSCLC patients who had experienced disease progression following treatment with Xalkori. Multiple products can have breakthrough therapy designation for the same indication, though according to recently released draft guidance from FDA, were one drug to receive FDA approval, all others in development for the same indication would lose the designation unless those products show substantial improvement over the newly approved therapy (see BioCentury Extra, June 25). ...