Biotech Values

[AlpineBV_Miller]

Is it safe to assume that, to ultimately gain approval, ARRY-380 is likely going to have to go head-to-head against T-DM1 and show non-inferiority or superiority? Perhaps ARRY (or hopefully a partner) will test 380 + T-DM1 vs. T-DM1 alone?

No. They could go (n)th line after the laundry list of stuff patients failed in the T-DM1 Phase II the FDA RTFed plus having them fail T-DM1, gemcitabine, and ixabepilone. That would be the unmet medical need.

Since her2+ pts in the US don't get gemcitabine and ixabepilone according to all teh docs who threw a fit after the FDA RTF, if I were ARRY I'd petition the FDA to convene ODAC for guidance on her2+ disease -- whether ix- and gem- are really indications if there is another her2-targeted drug available.

Frankly, that's what Roche should do while they're waiting for the second line trial to come in.