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schoonder · 02-18-2010, 02:31 PM

"keep this beast under control for the next few months the FDA will probably approve it"

Ellie F,
I'm not aware if Roche as yet has even applied for T-DM1 FDA approval.
They're very actively evaluating this drug, lots of data from two phase 2 trials in 3L MBC have been accumulated, also a worldwide 2L MBC phase 3 trial has been ongoing for well over a year, a number of combination trials as well as a headon phase 2 trial in 1L MBC setting vice herceptin with taxotere is presently being conducted.
However, while by now quite some time into this drug's evaluation, very little information has been published about real possibilities for compassionate use or early approval and if these options are indeed considered, the earliest date this could take effect.

02-18-2010, 02:31 PM	#3
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: scan results & new treatment update "keep this beast under control for the next few months the FDA will probably approve it" Ellie F, I'm not aware if Roche as yet has even applied for T-DM1 FDA approval. They're very actively evaluating this drug, lots of data from two phase 2 trials in 3L MBC have been accumulated, also a worldwide 2L MBC phase 3 trial has been ongoing for well over a year, a number of combination trials as well as a headon phase 2 trial in 1L MBC setting vice herceptin with taxotere is presently being conducted. However, while by now quite some time into this drug's evaluation, very little information has been published about real possibilities for compassionate use or early approval and if these options are indeed considered, the earliest date this could take effect.