BLA for T-DM1 has been submitted to FDA !
 

I just learned that today Genentech submitted the Biologics Licensing Application (BLA) to the FDA! I guess that means it could hopefully move swiftly into full access... but I don't know how swiftly these things happen. I'm still hoping for an expanded access location in the meantime... but this is great news.

Yay!

Re: BLA for T-DM1 has been submitted to FDA !
 

Bla bla bla....just get the stuff in our hands!!!!

Re: BLA for T-DM1 has been submitted to FDA !
 

yeah gals, get it in your hands in the States then maybe,just maybe we can start pushing for it across the pond!

Well done Chrisy on remaining NED, it seems like this is your magic bullet.

Ellie

Re: BLA for T-DM1 has been submitted to FDA !
 

Brenda, Thanks for posting this...so many of us our waiting...we need this out here now.

Chrisy...you said it all in your post. lol :)

Chelee

Re: BLA for T-DM1 has been submitted to FDA !
 

Today my doc said he thinks that a BLA comes with an automatic decision date that is either 60 or 90 days out. After that, if it is a go/approved by the FDA, then the only lag time will be getting the manufacturing systems in place to ramp it up for full access, and how long that takes is anyone's guess...

Re: BLA for T-DM1 has been submitted to FDA !
 

I seem to remember reading that FDA approval hinges on demonstrating process/intent/ability to mass manufacture. So...I'm thinking that's already underway.
But (always the but)..as I see with Provenge, FDA approval doesn't mean insurance is ready to deal with it. Medicare is still assessing coverage issues post FDA approval.


Private payers mull restrictions on Provenge[IMG]chrome://searchshield/content/safe.gif[/IMG]

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FiercePharma - Tracy Staton - 2 hours ago
How are insurers likely to treat Dendreon's (NASDAQ: DNDN) new prostate cancer vaccine Provenge? Very carefully, at least according to a new survey from ...
Dendreon (DNDN) 17% 4-Day Jump Raises Eyebrows; Is a Deal in the ...‎ - StreetInsider.com (subscription) (blog)
all 2 news articles »Dendreon Falls As Govt Starts Provenge Analysis[IMG]chrome://searchshield/content/safe.gif[/IMG][IMG]chrome://searchshield/content/vrsn-secured-lsfo.gif[/IMG]

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Wall Street Journal - George Stahl - Jun 30, 2010
The answer to that debate--the latest hurdle in Dendreon's push to get Provenge used--will affect sales of the costly treatment. If the Centers for Medicare ...
Dendreon: Medicare reviewing Provenge coverage‎ - The Associated Press
Why is Medicare Reviewing Dendreon's Provenge?‎ - Forbes (blog)
Medicare looking at Dendreon cancer vaccine‎ - Re