AP26113 Approval could come at any time based on existing data

Short Version of the Story: Ceritinib received FDA Approval based Phase One Trail data that was that was inferior to AP26113 Phase I/II data. As such, FDA approval for AP26113 could come at any moment, and the FDA might not wait for results from the Alta Phase II trial (for which recruitment is now underway).


Long Version of Story...

First of all, things can move quickly.  Let's take the Ceritinib, which received FDA Approval based on PHASE ONE trail data.  Here's the language about that data.

In April 2014, the next-generation ALK inhibitor ceritinib received an accelerated approval as a treatment for patients with ALK-positive NSCLC following progression on crizotinib. This approval was based on phase I data from the ASCEND-1 trial showing an overall response rate (ORR) of 58.5%. The early median duration of response was near 7.5 months - See more at: http://www.onclive.com/peer-exchange/nsclc-needs/Next-Generation-ALK-Inhibitors-in-NSCLC#sthash.g9PjxxjH.dpuf   Source 

Now, let's compare that to the AP26113 Phase I/II Trial Data Results (and note it's phase I/II, not just phase I):

The objective response rate (The objective response rate (ORR) in 72 evaluable patients with ALK-positive NSCLC was 72%. The median duration of response was 49 weeks. The median progression-free survival (PFS) was 56 weeks. In the 65 evaluable patients treated with prior crizotinib, the ORR was 69% with a median PFS of 47.3 weeks.  In 7 evaluable patients with treatment-naïve ALK-positive NSCLC, AP26113 demonstrated 2 complete and 5 partial responses, for an ORR of 100%. In patients with untreated or progressing brain metastases (n = 14), 71% of patients had evidence of radiographic disease improvement. - See more at link     

Now, you do the math.   AP26113 has better clinical data than a drug that the FDA recently approved based on Phase I Clinical Data.

The punch line is that AP26113 Approval could come at any time.