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First-line therapy with generic imatinib in chronic myeloid leukemia (CML) is associated with poorer outcomes compared with branded imatinib (Gleevec)


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#1 survenant

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Posted 24 February 2017 - 07:28 PM

See First-line therapy with generic imatinib in chronic myeloid leukemia (CML) is associated with poorer outcomes compared with branded imatinib (Gleevec).

 

See also      Generic Gleevec



#2 AdamJ

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Posted 25 February 2017 - 12:40 AM

Interesting, the conclusion drawn is different from what I found in this Blood Journal article that appears to be a more detailed account of the same study: http://www.bloodjour...ent/128/22/5451.


3/23/2016 Dx PCR 93.4399% IS, FISH 87%
3/30/16 Sprycel 100mg
4/15/2016 liver toxicity and a brief stint on Tasigna 600mg book-ended by drug breaks
6/6/2016 resumed Sprycel at 50 mg increased to 70 one month later followed by 100mg
6/17/2016 FISH Test 2%
8/22/2016 PCR 0.0035% IS
11/7/2016 PCRU
12/29/2016 PCRU
4/5/2017 PCRU
6/28/2017 PCRU
10/26/2017 PCRU


#3 Gail's

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Posted 25 February 2017 - 01:33 AM

Noticed in both articles that it was a really small sampling. It's good someone is looking at this, just wouldn't draw firm opinion from this small study.
Diagnosed 1/15/15
FISH 92%
BMB 9:22 translocation
1/19/15 began 400 mg gleevec
1/22/15 bcr 37.2 IS
2/6/15 bcr 12.5 IS
3/26/15 bcr 10.3 IS
6/29/15 bcr 7.5 IS
9/24/15 bcr 0.8 IS
1/4/16 bcr 0.3 IS
Started 100 mg dasatinib, mutation analysis negative
4/20/16 bcr 0.03 IS
8/8/16 bcr 0.007 IS
12/6/16 bcr 0.002 IS
Lowered dasatinib to 70 mg
4/10/17 bcr 0.001 IS
Lowered dasatinib to 50 mg
7/5/17 bcr 0.004 IS
8/10/17 bcr 0.001. Stopped TKI in prep for September surgery.
9/10/17 bcr 0.006
10/10/17 bcr 0.088

#4 Buzzm1

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Posted 25 February 2017 - 04:09 AM

Novartis's brand name Gleevec is continuing to lose more market share to generic imatinib mesylate.  Apotex generic imatinib mesylate is now available in the $2,100/mo. range via Express Scripts thru Walmart.  The price of the generic now available from Sun, Teva, and Apotex, will only go lower.  Even though the generic may appear different, the FDA requires that generic medications contain the same active ingredients as the brand name, and they function comparably in your body.  Novartis still has a patent on the inert filler ingredient they use for Gleevec; that patent expires in 2019.

 

In Canada, generic imatinib mesylate, manufactured by both, Teva and Apotex, has been on the market for 3-4 years, without any valid reports of inferiority to the brand name Gleevec.


For the benefit of yourself and others please add your CML history into your Signature

 

02/2010 Gleevec 400mg

2011 Two weakly positives, PCRU, weakly positive

2012 PCRU, PCRU, PCRU, PCRU

2013 PCRU, PCRU, PCRU, weakly positive

2014 PCRU, PCRU, PCRU, PCRU (12/07 began dose reduction w/each continuing PCRU)

2015 300, 250, 200, 150

2016 100, 50/100, 100, 10/17 TFR

2017 01/17 TFR, 04/18 TFR, 07/18 TFR 0.0012, 08/29 TFR 0.001, 10/17 TFR 0.000

2018 01/16 TFR 0.0004 ... next quarterly PCR 04/17

 

At the earliest opportunity, and whenever possible, lower your TKI dosage; TKIs are toxic drugs and the less we take longterm the better off we are going to be ... this is especially true for older adults.  

 

In hindsight I should have started my dosage reduction two years earlier; it might have helped minimize some of the longterm cumulative toxic effects of TKIs that I am beset with.  

 

longterm side-effects Peripheral Artery Disease - legs (it's a bitch); continuing shoulder problems, right elbow inflammation.   GFR and creatinine vastly improved after stopping Gleevec.

 

Cumulative Gleevec dosage estimated at 830 grams

 

Taking Gleevec 400mg an hour after my largest meal of the day helped eliminate the nausea that Gleevec is notorious for.  

 

Trey's CML BlogStopping - The OddsStop Studies - Discussion Forum Cessation Study

Big PhRMA - Medicare Status - Social Security Status - Deficit/Debt


#5 r06ue1

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Posted 27 February 2017 - 06:26 AM

As Buzzm1 stated, the FDA requires the generic to have the same active ingredients as the brand name.  If there is a problem, than it is with the insurance industry, not with the medication.  People that need to be put on a second generation drug at diagnosis are now being put on generic imatinib instead as a cost savings to the insurance industry.  This is where they need to target their studies.  

 

Profit margins and bottom lines will always come first in this economic system.


08/2015 Initial PCR: 66.392%

12/2015 PCR: 1.573%

03/2016 PCR: 0.153%

06/2016 PCR: 0.070%

09/2016 PCR: 0.052%

12/2016 PCR: 0.036%

03/2017 PCR: 0.029%

06/2017 PCR: 0.028%

09/2017 PCR: 0.025%

12/2017 PCR: 0.018%

 

 

Taking Imatinib 400 mg





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