[Debbie L.]

when company does go after a "targeted" drug, i.e. t-dm1 for Her2+ mbc treatment, FDA insists that "all" prior approved bc therapies, targeted or not, are included in the study

Yes, I agree, that ruling made no sense to me either -- how could (on average) SEVEN prior therapies not be enough? But I've since learned that the above explanation is not the FDA's explanation, or at least not their full explanation. Because of proprietary licensing rules the FDA is not allowed to divulge their thinking. What we know of the FDA ruling on TDM-1 comes only from the drug company. Surely, part of the reason the FDA denied accelerated approval for TDM-1 sits upon the phase 2 non-randomized data that was submitted to obtain that approval. Yet Roche/ImmunoGen did not mention that reasoning in their press release. And their press release is the only information we are privy to.

It's frustrating. The FDA has this new "transparency" initiative, but they are bound by legistlation (that protects the drug companies) not to reveal their assessments, unless the issue is taken to ODAC, or the company voluntarily discloses the whole story.