Subcutaneous herceptin gets EU approval

[Lani]

As I said in a previous post, a Genentech/Roche representative I met at ASCO
said they have no intention to file for approval with FDA any time soon (not sure why not)

http://www.reuters.com/article/2013/09/02/us-roche-herceptin-idUSBRE98103A20130902

[Ellie F]

This is the first hurdle for us in the uk! We will have to see if NICE approves it!
Ellie

[sarah]

this sounds great! I wonder if they did this now in order to keep the patent going, still it's very good news.
sarah

[michka]

Thanks Lani. This is really good news for all patients.

Why are they not filing for FDA approval? I don't always understand what the labs are really doing. For TDM1 they pushed in the US but we are still waiting in Europe and they do not seem to be in a hurry. For this new form of Herceptin it is the other way around.

[tricia keegan]

Thanks Lani!