HER2 Support Group Forums - View Single Post - T DM-1 Approved !!

phil · 02-28-2013, 08:51 AM

I think 9,600 $ per dose, every 3 weeks , un-fortunately. Comparable to other recent tx's. Gen. may help some with income issues.
Wish This FDA did give proper sense of urgency to this drug . did they have to reject using expanded access data back in 2010 ? never think about shortening the trail over the past 2 and a half yrs ? giving t dm-1 any special consideration , based on the great stats in 2010 ( far better than tyk. , which previous admin. gave acclerated appr to ) ?
Did they have to take 6 full months for a " priority " review , with data last Sept. saying that 65 % of EMILIA pts getting t dm-1 had lived TWO YRS or more ??
No , but they did, because its not their wife or daughter, sister.
What have u heard about Perjeta getting to stage iv , since partial approval last June ? How urgent is This FDA with that ?
Didnt the old FDA stop the Phase III trial for original Herceptin before it finished ? What excuse do they have in 2012 ?

02-28-2013, 08:51 AM	#50
phil Senior Member Join Date: Nov 2010 Posts: 393	Re: T DM-1 Approved !! I think 9,600 $ per dose, every 3 weeks , un-fortunately. Comparable to other recent tx's. Gen. may help some with income issues. Wish This FDA did give proper sense of urgency to this drug . did they have to reject using expanded access data back in 2010 ? never think about shortening the trail over the past 2 and a half yrs ? giving t dm-1 any special consideration , based on the great stats in 2010 ( far better than tyk. , which previous admin. gave acclerated appr to ) ? Did they have to take 6 full months for a " priority " review , with data last Sept. saying that 65 % of EMILIA pts getting t dm-1 had lived TWO YRS or more ?? No , but they did, because its not their wife or daughter, sister. What have u heard about Perjeta getting to stage iv , since partial approval last June ? How urgent is This FDA with that ? Didnt the old FDA stop the Phase III trial for original Herceptin before it finished ? What excuse do they have in 2012 ?