Breakthrough designation here is significant because LDK is a very similar molecule that already received BTD and approval, which surely raises the bar some for BTD.
Indicates to me that the FDA believes (as I do) that '113 has significant advantages over LDK - likely the brain mets are the key. Perhaps also potential usage 3rd line given there was a response in a patient that had failed both LDK and crizotinib.
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