FRI DEC 17 - Genentech stakeholder call to discuss TDM1 (FDA) decision

[hutchibk]

Dear Advocates,

In response to FDA’s announcement, Genentech invites stakeholders to participate in a call to discuss the decision. The Genentech stakeholder call is scheduled for Friday, December 17th at 12PMPT/3PM ET. Call information is as follows:

Participant dial-in: 866-545-4643
Conf. ID # 32970793

The call is open to the public – we welcome you to forward this invitation to any interested parties.

Please let me know if you have any questions.

Thanks,
Sonali

--
Sonali Padhi
Senior Manager, Advocacy Relations
Genentech, Inc.
650.467.0842
sonalip@gene.com

[hutchibk]

I have a doctor's appt at 2:30 cst tomorrow, so I will probably only be able to listen in on half of it on my cell phone... I hope someone here on the board is able to participate and takes notes! If so, please post them!

[chrisy]

Is this a call re the Avastin decision?

[Chelee]

Chrisy,
Brenda's subject line says it for T-DM1. I just keep hoping we get some unexpected good news on T-DM1 soon. I had a 2nd opinion with a well known onc and he said T-DM1 should be released to all this coming fall. (I think next wk would be better.) :)

Chelee

[ElaineM]

I hope this means good T DM1 news. It would be great if they are going to approve it faster than expected. Let's keep our fingers crossed.

[chrisy]

The reason I asked is because the only "announcement"
From the FDA was the avastin one. Call me skeptical but I doubt that good news, particularly unknown good news would prompt a public "all stakeholders call"

Bbut maybe I'm wrong it's happened before a couple of times I think. Guess I'll have to log onto the call!

[StephN]

I also got this announcement and the title of the email was: "Genentech Stakeholder Call Friday Dec 17 12pm PT/3 pm ET"

Nothing about which drug they want to discuss

I have to work away from a computer tomorrow, so will be looking forward to a report when I get home.

Would love to be a fly on the wall. We met the woman from Genentech who sent out this message at their Advocates Reception in San Antonio.

[Sheila]

also got an email from Sonali about this, and brenda lso sent me a copy...I hope to listen and participate

[chrisy]

I just got off this call. It was regarding the FDA action to revoke approval for Avastin for breast cancer. There was no discussion on TDM1, however there was discussion that was somewhat helpful on how to impact and/or participate in the appeal hearing process as Genentech appeal the decision.

The appeal process is Gene has 15 days to submit a request for hearing, then 30 days to submit documentation. Then the FDA decides whether to allow a hearing. If a hearing is granted, it is a public meeting chaired by the FDA.

There is a process to get comments on the docket for this, login info for this is:
log into
www.regulations.gov (http://her2support.org/vbulletin/www.regulations.gov)
then enter in search
FDA-2010-N-0621.

This takes you to a page with the document sent by the FDA to Genentech and also has sections to add a comment.

This was good information, and the Genentech participants emphasized that interested parties should take this opportunity to comment, as this becomes part of the official public record and part of the proceedings.

They really need patients and advocates to be vocal - and this was a recurring theme I also heard at San Antonio. That clinicians and researchers and pharmceutical co's are limited in what they can say. But as patients we are not.

So, some good information, not on TDM1 topic at all...

[StephN]

Chrisy, I was also able to listen in as it was not too long. We met the doctors who moderated the call at the Genentech Advocates Reception on Thursday, Dec 9, in San Antonio.

It was quite heartening that the people from the Genentech side were really mixing with the attendees and making sure we knew each Gen. employee's position plus had their contact information.

MAIN POINT to note is that the European trials came out with THE OPPOSITE conclusions from Avastin data as our FDA. Gen. is seeking comments from the public/patients that will back up the European findings.

Another important point is that until the appeals process has gone its full route the drug is still approved for appropriate patients, including those getting it off label or with other drugs such as Xeloda.

There was a question from a woman from one of the Ovarian Advocate Groups. They are afraid that indication may also be on the chopping block. The Gen. oncologist, Dr. Horning, mentioned that there is also a phase III trial in progress with Avastin for brain cancer.

Perhaps since it is an expensive drug the FDA is wanting to limit its use to the best-responding cancers. Just a thought.

[hutchibk]

Yeah, oops, I have TDM1 on the brain... I meant to type Avastin. Sorry for confusion.

[StephN]

Well, NO WONDER, Brenda dear!

You have been fighting to get this drug for unpteen weeks now ...

[iamlisaann]

I am currently on the clinical trial Avastin/Tykerb. I have been since April 2008. I just rediscovered the her2support forum. So glad to see such wonderful women survivors here.