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DewDiligence

11/14/11 11:13 AM

#131018 RE: biomaven0 #131015

ARIA—There might also be a regulatory issue - Tasigna and Sprycel I think still have to do a confirmatory trial in front line and so I believe aren't eligible as the only comparator (but I'm not sure about this).

I don’t think that’s correct. As far as I know, the only remaining post-marketing requirement for Tasigna is the reporting of 5-year data from the extension of the pivotal trial in the first-line setting (http://www.clinicaltrials.gov/ct2/show/NCT00718263 ).
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NP1986

11/14/11 8:09 PM

#131072 RE: biomaven0 #131015

I don't mean mean head-to-head in the first line setting, but rather in the second line setting. If the contention is that second generation TKIs and ponatinib will struggle to make inroads into the first line market once Gleevec goes generic, then the second line market is perhaps a more realistic target for Ariad.

Some posters have commented that ponatinib will become the de facto second line therapy of choice; however, I don't see it as a given based solely on the results of PACE.

As for getting a foot in the door in the front line setting, I don't think Ariad has much time to do that. It took Sprycel and Tasigna three years to get a first line indication, after initiating their respective first line phase III trials.