Ipilimumab renamed Yervoy

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11/10/2010 10:26pm
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Replies: 13

BMY is changing the name in anticpation of FDA approval.  There will be a meeting on Dec 2.  Here is an excerpt about the meeting  and a link to the FDA site for more information:

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

  • Written submissions may be made to the contact person on or before November 16, 2010.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm230348.htm

lhaley - (11/10/2010 - 11:17pm)

Jim,

Thanks for the post! Someone recently posted that the FDA hearing had been put off for a few months, I hope that this one  isn't an old announcement.

When I saw my mel specialist before my surgery he said that  when ippi was approved it would be under the guidelines of some of the trials that you had to have measurable disease.  He didn't comment that you would have had to already received prior therapy.  So I guess we will still have to go through something else first by reading the announcement.

Hope your doing well!

Linda

Jim in Denver - (11/11/2010 - 11:14pm)

Hi Linda,

As far as I can discern, measurable disease would be required, but not prior (unsuccessful) treatment.  Once approved, compassionate use would not be available for new patients.  I am doing well, thanks!

Best,

Jim

swissie - (11/11/2010 - 4:03am)

Jim,

I'm afraid this might be old information. Last week the FDA announced they will decide a on ipi only in March. Although this meeting on the 2nd of December might take place, the decision will not.

Your page was last updated on 10/20/2010 which was before the decision change.

I was just looking into this subject yesterday, that's why I know.
 

Jim in Denver - (11/11/2010 - 11:22pm)

Swissie,

This might be old information, but that does not mean it is wrong.  I follow this stuff pretty closely, which you would know if you looked at some of my postings.  As a Stage IV patient who is receiving Ipi, I actually know what I am talking about (unfortunately).  The "news" from my post is about the new name, and that is really all.

I am glad you do your own homework and are an expert on the FDA approval process in the USA, however.  I don't know what you are talking about saying my "page was last updated on 10/20/10", or why that has anything to do with anything. 

Jim

swissie - (11/12/2010 - 4:39am)

Hi Jim,

First of all I'm sorry if I offended you in any way. That was absolutely not my intention.

I am not an expert in any way, and that is not how I wanted to say this.
I am a stage III patient, participating in a double blind trial with ipi.  I hope never to become stage IV because of ipi! That is the reason I follow this as well. I would like to have ipi approved just as much as you do!
I do not post here very often, but that does not mean I do not follow what's going on.

All I wanted to say in my reply is that I fear that the meeting might not be on December 2nd, as the approval of ipi (or Yervoy) is delayed to March. As this was only communicated by the FDA last week, and the FDA link you posted was updated earlier, I only wanted to point out that the meeting might be postponed as well.

So far I could not find out why they had to postpone. My trial doctor told me they still don't have enough patients participating in the different trials, but I don't know if that is true. Do you have any idea?

It's really a shame that we all have to wait for a medication that seems to work, and when it finally can be approved, the approval is delayed!

 

 
 

 

Jim in Denver - (11/12/2010 - 11:13am)

Swissie,

There is obviously intense interest in this subject of Ipi/Yervoy approval around here, regardless of the name.  Pharma cos tend to choose some really odd names, don't they?  The dance with the FDA continues, and approval delayed.  I am sure I don't know all the details, nor does anyone else except for the people at BMY and FDA.  There will be a meeting with public comments (written and oral) taken, whether on December 2nd or later. The FDA has had some "fast track" or expedited approvals come back and haunt them, so they are probably more cautious these days.  More info here:

http://www.fiercebiotech.com/story/fda-delays-decision-bms-cancer-drug-ipilimumab/2010-11-02

I am not sure there is a clear understanding that the eventual approval means the end of the trials under which Ipi has been available.  I am not really clear on all the changes myself, but I do know it will not be available at zero cost.  After approval, the process to obtain the medcine will change, and there should be (will be) more discussion about this.  There will be pros and cons after approval, but it would appear that wider availability will come with a fairly high price tag.  Some "experts" are guessing that BMY will price Ipi at somewhere near $5000 per treatment.  That might be on the high side, but you can be assured it will not be inexpensive.  How the cost factors into availability (insurance coverage, primary vs secondary treatment, etc) will bear watching.

Hope you are in the arm in your trial that is receiving Ipi.  It makes sense that Phase IIIers should benefit from earlier treatment, and that it could help prevent further progression as well as induce regression in some cases.  You should be able to tell if you are getting the real stuff after the 3rd or 4th infusion by side effects (or lack therof).  Many side effects have been mentioned on this board, whihc you have probably noticed  - the common ones you would get would include significant rash with a very persistent itch.

Best Wishes,

Jim

Jim in Denver - (11/12/2010 - 11:14am)

I meant Stage IIIers, obviously :)

Jim in Denver - (11/12/2010 - 12:30pm)

Swissie,

You have no need to apologize, but I do, so I apologize for the tone and content of my initial reply.  I do try to follow this stuff closely.  One of the best things about this board is the shared collective knowledge, and hopefully we become more knowledgeable but putting all these pieces of the puzzle together.

Your Doc is speculating, but my guess is that BMY does not lack for data.  What is probably happening is that FDA is asking for trial data that BMY has not shared with them to date.  There are studies that have been completed but no data has been made available publicly, including to the FDA.  That seems to be the issue with the delay.  It would be easy to speculate that the data that has not been shared with FDA may not be quite as favorable as the data that they have provided with the initial approval request.  Who knows if late March will conclude the process?

Best,

Jim

swissie - (11/12/2010 - 4:40am)

Hi Jim,

First of all I'm sorry if I offended you in any way. That was absolutely not my intention.

I am not an expert in any way, and that is not how I wanted to say this.
I am a stage III patient, participating in a double blind trial with ipi.  I hope never to become stage IV because of ipi! That is the reason I follow this as well. I would like to have ipi approved just as much as you do!
I do not post here very often, but that does not mean I do not follow what's going on.

All I wanted to say in my reply is that I fear that the meeting might not be on December 2nd, as the approval of ipi (or Yervoy) is delayed to March. As this was only communicated by the FDA last week, and the FDA link you posted was updated earlier, I only wanted to point out that the meeting might be postponed as well.

So far I could not find out why they had to postpone. My trial doctor told me they still don't have enough patients participating in the different trials, but I don't know if that is true. Do you have any idea?

It's really a shame that we all have to wait for a medication that seems to work, and when it finally can be approved, the approval is delayed!

 

 
 

 

KatyWI - (11/11/2010 - 8:49am)

We could use a little light-hearted humor around here...so let me be the first to say that "Yervoy" is almost as silly of a name as ipilimumab.  At least it's pronounceable.  But Yervoy sounds like a character from Fiddler on the Roof or something...!

KatyWI

Just keep going!

glewis923 - (11/11/2010 - 7:18pm)

Now THAT's funny-

Love, Rabbi Boris Yervoy.

I'm Here for Now, I've got the rest of my life to die; and if so, old age could be overated and God does exist.

Jim M. - (11/12/2010 - 7:46pm)

I like Ipilimumab better than Yervoy because Ipi is so tongue twisting. I feel so much control now that I have the pronunciation down, it just rolls off my tongue while others, especially outside the walls of cancer hospitals don't have a clue as to what I'm saying. Just feel the power of that!!!  Yervoy is boring! Just my humorous 2 cents worth.

 Jim M.

Jim in Denver - (11/12/2010 - 10:26pm)

I feel the same way, Jim.  I think all the Pharmas hire consultants to come up with these ridiculous names!