Does anyone have news about the TDM1 announcement?

michka · 02-13-2013, 05:36 AM

I don't see anything about it anymore and we are already mid February.
Any information to share? Thanks. Michka

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.

ElaineM · 02-13-2013, 05:43 PM

We could check on the Genetech website at www.gene.com for some kind of press release after February 26th.

phil · 02-13-2013, 07:56 PM

i think it will be anyday, one clue may be FDA Commissioner is going to be the featured speaker at Mass Biotech Coucil Annual Mtg. march 14, 15. and featured drug presentation is " Antibody Drug Conjugates ", the fancy name for t dm-1 type drugs. Boston is now a world center for biotech. is she really coming all the way to Boston to give bad news to the pharma co's. i think not. why have they waited to the end of review time ? can only speculate :
because they can ? , flexing thier regulatory muscles ? , or looking for any s/e to play up as an excuse for thier mis-mgt. of this special drug ? or , maybe they plan to treat it as the special drug it is , and approve for all who progress on herceptin ? the last one is a stretch for This FDA , they havent thought outside their 1980's box with this drug since 2010.

phil · 02-13-2013, 08:01 PM

and remember, approval decision making is supposed to be secret , to prevent insider trading.

sarah · 02-14-2013, 05:18 AM

Michka, how's it going? have you finished with your TDM1 treatment?
thinking about you. Are you as sick of the cold weather as we are here in the south?
hugs and love
sarah