HER2 Support Group Forums - View Single Post - Does anyone have news about the TDM1 announcement?

schoonder · 02-13-2013, 07:13 AM

Michka,
Expect a response from FDA no later than Feb 26 to Roche's request for approval of T-DM1. Keep fingers crossed response will be an approval and not some kind of request to provide further information.
Approval for this drug has also been applied for in Europe and Japan, responses anticipated by 2nd half 13 and early 14 resp.

02-13-2013, 07:13 AM	#2
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: Does anyone have news about the TDM1 announcement? Michka, Expect a response from FDA no later than Feb 26 to Roche's request for approval of T-DM1. Keep fingers crossed response will be an approval and not some kind of request to provide further information. Approval for this drug has also been applied for in Europe and Japan, responses anticipated by 2nd half 13 and early 14 resp.