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Ponatinib Fails FDA Approval?


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#1 wallystl

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Posted 02 October 2012 - 12:10 PM

I was at Cancer center yesterday and they told me the Ponatinib Trial has been extended 96 more months because titdidn't get FDA approval as expected.  Anyone have any additional news on  this?

Thanks, Wally



#2 scuba

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Posted 02 October 2012 - 12:23 PM

http://seekingalpha....second-line-cml


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"


#3 CallMeLucky

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Posted 02 October 2012 - 02:22 PM

Everything I have read has shown that ponatinib is being fast tracked for approval with FDA.  They are expecting to be approved for second line treatment in Q1 of 2013 and pushing for first line treatment approval by 2015.

The only thing I can think of is maybe they were confused about the issue with the MolecularMD test that was seeking approval with ponatinib.  It was determined it was not necessary to have the test.

http://www.genomeweb...blish-ponatinib


Date  -  Lab  -  Scale  -  Drug  -  Dosage MG  - PCR
2010/Jul -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 1.2%
2010/Oct -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.25%
2010/Dec -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.367%
2011/Mar -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.0081%
2011/Jun -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2011/Sep -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.00084%
2011/Dec -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Mar -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.004%
2012/Jun -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Sep -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Dec -  MSKCC  -  Non-IS  -  Sprycel  - 100 - 0%
2013/Jan -  Quest  -  IS  -  Sprycel  -  50-60-70  - 0%
2013/Mar -  Quest  -  IS  -  Sprycel  -  60-70  - 0%
2013/Apr -  CUMC  -  Non-IS  -  Sprycel  - 50 - 0.036%
2013/May -  CUMC  -  Non-IS  -  Sprycel  - 50 - 0.046%
2013/Jun -  Genoptix  -  IS  -  Sprycel  - 50 - 0.0239%
2013/Jul -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0192%
2013/Jul -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0034%
2013/Oct -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0054%
2014/Jan -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0093%
2014/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0.013%
2014/Apr -  Genoptix  -  IS  -  Sprycel  - 100 - 0.0048%
2014/Jul -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2014/Nov -  Genoptix  -  IS  -  Sprycel  - 100 - 0.047%
2014/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0.0228%
2016/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Dec - Genoptix  -  IS  -  Sprycel  -  100 - 0%
 

 


#4 Trey

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Posted 02 October 2012 - 03:42 PM

Ponatinib has not failed anything with the FDA.  The company (ARIAD) just sent the second half of the submission to the FDA last week.  FDA allows "rolling submissions" where data is sent as it is available, and Ponatinib is being done this way.  So FDA has not had anything to either approve or disapprove yet.  So there have been no decisions or announcements at all from the FDA related to Ponatinib.



#5 wallystl

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Posted 05 October 2012 - 08:56 AM

OK Thanks everyone.  I guess there is a difference between "failing" and whatever other term one could use.

I was told in the spring that the drug was probably going to be FDA approved bu mid summer and it was to be written up in NEJM.

On Monday I was told it wasn't FDA approved and that the trail (I'm in the trial) was extended from the original 2 years to an additional 96 months.

So, no failure, no approval. I'm just a little concerned and wondering if I should look into other options or hang in there.  One of the difficult things about the trial is the BMB every 90 days.  I had one Monday and it was the worst one ever. Took the guy 1.5 hours.  He had to give up and call in another tech.  I'm black and blue and still very raw.

Wally



#6 ritan/

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Posted 05 October 2012 - 10:37 AM

holy cow. i swore after the one that took 50 minutes (the only one i've had) that i wouldn't have another without a general anesthetic. i can't imagine.

hugs



#7 HPL

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Posted 05 October 2012 - 12:08 PM

Hi Wally,

I don't think there was any realistic chances of the drug being approved by this past summer, considering that Ariad was in the middle of submitting their FDA application. So that data was sketchy. I am a phase I trial patient, and nothing has changed in our protocol recently. I actually had the oppertunity to meet quite a few of the management team at Ariad in September and got to attend their company meeting, and from everything I learned, it's on track for approval sometime early 2013. Ariad has done everything that they were asked, now it's in the FDA's hands. I would stay the course, if the drug works, then you're in good hands.

The BMB did move to every 180 days for us in Phase I, you should expect that that duration should increase for you as well soon. Sorry to hear about your BMB experience, I would ask for a different technician next time, it isn't supposed to be that bad. Are you in the official Phase 2 trial, or the expanded study ?

Regards,

Hans

Zavie # 1303.



#8 TeddyB

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Posted 05 October 2012 - 03:21 PM

1.5 hours? I waited 10 minutes for the local anesthetic to work, and then the procedure itself took 5 minutes at most. Get a new guy to do it next time.



#9 wallystl

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Posted 06 October 2012 - 08:35 AM

Gee Teddy, thanks for that great advice!  I'm honored that you took time from your day to provide me with such earth shattering info. 

Perhaps you could share with the group here the name of the Dr. with the 15 minute bone marrow biopsy special so we can all benefit from such medical wizardry.



#10 Melanie

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Posted 06 October 2012 - 11:51 AM

So sorry to hear about your horrible experience with your BMB. I just got one Tuesday and was very aprehensive. I've had 3 previous...1st one without being put out, which was very painful and awful, then 2 done under general anesthesia, the last one leaving me sore and black and blue for a month. This one I received at MD Anderson due to a special consultation and when they told me they weren't putting me out...my anxiety went through the roof. They re-assured me that the BMB techs are very experienced and that the procedure is all they do and I would be fine. As it turned out, they were right. Whole thing took 20 minutes and they even took extra for a research study. I did feel pressure and mild discomfort, but was totally okay. Was a little sore for a couple days and expected to see the usual bruising, but as of today,4 days later, no bruise and soreness is gone. So, I surmise that it's all in the experience of the person doing the procedure. I have another one scheduled in 3 months, so we'll see if I just got lucky or not. I pray you have a much better tech and experience next time.

Melanie


Dx - 05/2011; PCR: 15.04; Fish: 87% Slow responder due to pancytopenia. Current - Bosulif - Nov: 2012, Mar 2016 lowered to 300 mg. 07/16 back to 400 mg. Clinical trial drug, Promacta, Feb 2013, for low Platelets.
CyCR - Aug 2014, Positive for 1 chromosome Sep 2015. PCR: 12.77 in Oct, 2012 to 0.04 (MDA) in Mar, 2016. 4/2016 - 0.126 (Local lab (IS); 05/2016 - 0.195 (local); 6/2016 - 0.07 (MDA); 7/2016 - 0.03 (local) 9/13/2016 - 0.16 (MDA); 9/26/2016 - 0.31 (MDA); 11/2016 - 0.012 (local); 01/2017 - 0.24 (MDA); 04/2017 - 0.09 (MDA); Cytogenetics show der(1:7)(q10;p10)7 chromosome mutation. Repeat of Sep 2015. PCR - 6/2017- 0.035 (local); 10/2017- 0.02 (MDA)

#11 TeddyB

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Posted 06 October 2012 - 05:05 PM

wallystl: The downside is he only does BMB in the sternum, and he does his "medical wizardry" in Oslo/Norway.

My next BMB will be with a different onc, so who knows, maybe ill get the 1.5 hour bmb next time.

Sorry if i have offended you in any way, that was not at all my intention.

Teddy






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