Tagrisso approveal - 1271827

wadvocator
Posts:79

The EGFR community might be interested

http://www.curetoday.com/articles/fda-approves-tagrisso-for-resistant-n…

Approved 3 months ahead of schedule

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Reply # - November 15, 2015, 06:01 PM

carrigallen
Posts: 194

Yes this is a landmark approval. Its great when a new drug has both good efficacy and noticeably fewer side effects, than available treatment. This is the kind of standard we should set for new drugs.

Reply # - November 16, 2015, 08:23 AM

wadvocator
Posts: 79

Thanks Dr. Creelan! Is Tagrisso likely becoming the new standard for treating EGFR mutation or only for T790? Will it work for EFGR mutation not currently showing signs of T790?

Reply # - November 16, 2015, 09:25 AM

JimC
Posts: 2753

Until there is good evidence that it leads to an improvement in overall survival when used in the first line setting, that's not too likely. You'd like to be able to get maximum benefit from Tarceva, then additional benefit from a third generation EGFR inhibitor such as Tagrisso.

Here is a recent discussion of that question: http://cancergrace.org/lung/2015/11/13/lcam_2015_west_third_generation_…

JimC
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Reply # - November 16, 2015, 01:46 PM

eileendsmith
Posts: 3

Hi! First time poster because my sister was doing so well on tarceva and then clovis (dx 2010). Recently her cancer spread to her brain -- showed multiple mets on the outer lining. She had whole brain radiation for 2 weeks about a month ago and last week she started feeling really dizzy/nauseous. Today her MRI showed that the cancer had spread to her brain stem. Her oncologist wants to put her on Tagrisso ASAP, possibly on a double dose. (I assume this is aggressive.)

While I can find literature on Tagrisso's impact on the lungs I can't find anything on how it would help the brain and existing mets -- except for the idea that it can cross the blood-brain barrier. Does anyone have any additional information? What did the study/trial show? Thanks so much for any help.

Eileen

Reply # - November 17, 2015, 11:38 AM

carrigallen
Posts: 194

Tagrisso is approved for EGFR mutant lung cancer with T790M mutations. It is unlikely to have good brain penetration, because of the P-gp and BCRP transporter proteins.

Reply # - November 17, 2015, 12:44 PM

eileendsmith
Posts: 3

Hi Dr. Creelan. Thank you for your quick response. My sister's oncologist was weighing whether to use Tarceva pulsing versus Tagrisso but decided on Tagrisso. (Tarceva had kept her cancer at bay for 2 years but when it pooped out she was switched to Clovis, which didn't show the same potential of crossing the blood-brain barrier.) What do you see as the major difference between the two protocols? Thank you so much.

Eileen

Reply # - November 17, 2015, 03:41 PM

catdander
Posts:

HI Eileen,

Welcome to Grace. I'm sorry your sister's in this situation. At this time the only pulsed drug used is tarceva in Leptomeningeal carcinomatosis (LC) so it's impossible to say what might be the better choice. Please keep us posted. It does make sense to try.

I hope your sister does very well.
Janine

Reply # - November 18, 2015, 09:53 AM

eileendsmith
Posts: 3

Thanks Janine - we're all hoping and praying for the best, obviously. She's been an outlier so far! Her oncologist referenced this trial with Tagrisso (albeit small) that had shown some success in crossing the blood-brain barrier: https://www.inspire.com/groups/american-lung-association-lung-cancer-su…

Definitely interested in hearing from anyone who's switching to Tagresso since the FDA approval. Thanks and will keep you posted.

Reply # - November 18, 2015, 03:38 PM

wadvocator
Posts: 79

FDA is asking Clovis for more data/information regarding its T790 drug. The original target date for approval was March 2016. So it appears that Tagrisso is the only approved drug for EGFR T790 situation for a while. Hope additional review process go well so that there can be competing treatments like Heptatitis C. Nothing drives down prices like competition!

Reply # - November 19, 2015, 02:17 PM

wadvocator
Posts: 79

I am hoping an expert can help answer this question:

Tarceva is the pill for treating EGFR mutation. It is my understanding that additional mutation can occur via T790. I am assuming that with T70 mutation, the blood stream will have cells with EGFR mutation and cell with additional mutation of T790. I think the literature indicated it by EGFMm. Does Tagrisso works on both the original EFGR mutation and the new T790 mutations in one's body?

Reply # - November 19, 2015, 04:18 PM

JimC
Posts: 2753

Hi wadvocator,

Yes, third generation EGFR inhibitors such as Tagrisso can successfully treat EGFR mutated cells, whether they bear the initial sensitizing mutations or the T790 mutation associated with resistance to first line EGFR inhibitors such as Tarceva.

That's why the question has been raised as to whether the third generation agents should be used as first line. This discussion concludes that although it is feasible, there is no evidence that overall survival improves by doing so.

JimC
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