Status of Tykerb (Lapatinib) FDA Approval?

Muldoonmom · 02-15-2007, 04:55 PM

Does anyone have any info on the current status/projected approval date and release of tykerb??? I'm anxiously awaiting its approval!
Thank you,
Debbie

Sandy H · 02-15-2007, 06:08 PM

San Antonio told us the drug company had filed the application last September and it can take up to 6 months. That puts it into March. I am not sure the exact day as I would have to look it up but its around the middle. I am patiently waiting myself and hope we don't get disappointed. Perhaps, Joe can give us more current info. hugs, Sandy

Sherryg683 · 02-15-2007, 06:32 PM

I was told that it had to be approved by mid March. My Oncologist told me yesterday that he was going to put me on it along with Herceptin...yeah!...sherryg683

Annemarie · 02-15-2007, 09:41 PM

Drug companies have something referrred to as "the pink sheet" that you can search FDA filing. I hope this helps.

rinaina · 02-15-2007, 10:19 PM

Sherry, I Thought You Can't Go On Both Herceptin And Tykerb Together. Maybe Due To Increased Risk To Heart? Perhaps Another Reason. Has Anyone Ever Been On Both And Are There Studies For This?

Muldoonmom · 02-16-2007, 05:26 AM

Thanks, Gals.
I am anxiously awaiting its approval - my doc has said that he will start me on it immediatly, along with Herceptin.
I'll check out the "pink sheet."
Debbie

Sandy H · 02-16-2007, 08:44 AM

There are trials using this combo. It was considered for me but there were no trials in my state so then I qualified for the Tykerb/Xeloda trial. Some docs are reluctant to put their patients on the combo because of the heart risk. Mugas will have to be done, I believe, every 6 weeks or at least to start. Wishing you well in your new treatment. hugs, Sandy

Sherryg683 · 02-16-2007, 10:41 AM

Someone posted this link below from the doctors who are in charge of the Tykerb/Herceptin trials being done. They sound very promising and seem to indicate that this will be the way to treat HER2+ cancer in the future. Something that I had read in "Cure" magazines about 8 months ago. It talks about the synergy of the two used together..one attacking the inside of the cells, the other the outside. I think it is too early yet to determine how bad the side effects are. From what my Oncologist has told me, tykerb is easier on the heart than Herceptin from what they have so far shown. I'm sure it's all yet to be seen. I am sure the age of the patient and physical condition will be taken into consideration before they are put on this combination without tons of research to back it. Before Cancer (a year ago) I worked out 5 days a week and played tennis 4 days, I was in the best cardio shape of my life. I still can go out and do 5 miles on the treadmill with no problem. I'd rather take a chance on my heart than letting this beast back in. My husband asked my Oncologist about putting me on the both and he said quote.."in her case I think I would definately consider going that way". I guess he meant, he thought I could handle it..I'm sure I'll be watched closely with mugas, as would be with any new combo they would try. The link below is very interesting to listen to about Heceptin/Tykerb.sherryg683
http://www.breastcancerupdate.com/do...8_06_Chang.mp3

vickie h · 02-16-2007, 03:28 PM

My Onc said that Tykerb should get the approval or an answer by mid March, but that after that, they would have to start getting insurance Cos. to start paying, and then start making enough of the drug which could possibly delay it for another few months, but hopefully not for those of you waiting. Love, Vickie

lindaw · 02-16-2007, 07:48 PM

Dear all

I know its very anecdotal but I feel the good initial response to Tykerb( skin mets on my arm just melted away) is due to the fact it was taken after the herceptin - whilst still in my system. I really want to try Herceptin and tykerb together , However I am not sure if Tykerb has ven been submitted to the TGA in Australai yet and fear it may be a long time . I am trying to find out about its approval in Australai but it is proving difficult.Joe - are you aware of any info?

love
linda

hutchibk · 02-19-2007, 12:12 AM

Here's a VERY informative article. It almost made my brain explode, but it sure does cover a lot of ground and alot of questions about Tykerb, Herceptin and the combination of the two. It opens up a lot of new questions for me and my doctor to talk about...

http://pubs.acs.org/cen/coverstory/84/8432cancer.html

Cheers to a successful combo of Tykerb/Herceptin for all of us!