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Generic Gleevec FDA Approved


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#1 hannibellemo

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Posted 04 December 2015 - 06:06 PM

Saw this on Google news!

 

http://abcnews.go.co...a-pill-35581530

 

(perhaps this is old news and I just need to get out more)


Pat

 

"You can't change the direction of the wind but you can adjust your sails."

DX 12/08; Gleevec 400mg; liver toxicity; Sprycel 100mg.; CCyR 4/10; MMR 8/10; Pleural Effusion 2/12; Sprycel 50mg. Maintaining MMR; 2/15 PCRU; 8/16 drifting in and out of undetected like a wave meeting the shore. Retired 12/23/2016! 18 months of PCRU, most recent at Mayo on 7/25/17 was negative at their new sensitivity reporting of 0.003.<p>


#2 Buzzm1

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Posted 04 December 2015 - 06:21 PM

Saw this on Google news!

 

http://abcnews.go.co...a-pill-35581530

thanks for the info Pat

at Kaiser, Gleevec 400mg is $132,000 per year

Gleevec 100mg is $100/pill

 

awaiting news on the U.S. generic Gleevec pricing ... 


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


#3 chriskuo

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Posted 05 December 2015 - 03:53 AM

The article indicates that Sun will have exclusive rights to sell generic gleevec for 6 months (from Feb to August).  After that, if additional manufacturers are approved, the price should drop more.



#4 Grateful9771

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Posted 07 December 2015 - 01:56 AM

This is great news!  I have been on 600 mg of Gleevec since October of 2009 with great results.  Currently my corporate insurance has a co pay of $35 which covers the $16,266.00 medication every month.  I just turned 59,  looking forward to the possibility of retirement in the next 10 years.  A friend of mine also has CML  retired about a year ago and is getting her medication thru medicare.  She owns her own home and is having to pay about $800.00 a month out of her own pocket to cover the medication.  This adds up to about $10,000 a year.  I have not adequately saved to pay that kind of premium in retirement for my monthly meds.    Generic Gleevec would seem to be a big step in the right direction to help reduce this monthly expense in retirement.  



#5 r06ue1

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Posted 07 December 2015 - 06:25 AM

Yeah, I learned of this a few months ago while researching my newly diagnosed condition, I was absolutely shocked at the price my insurance company was paying (over $10,000 for a 30 day supply, a bit exorbitant if you ask me) and also have the worry about how to pay for my medicine if I were ever to lose my insurance.  I am also a disabled vet and found out that the VA would have my back but others may not be so lucky.  Hopefully anyone that needs the medicine will always be able to get it as it would be a tragedy for anyone to die due to money.


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


#6 Buzzm1

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Posted 07 December 2015 - 12:21 PM

I have been on 600 mg of Gleevec since October of 2009 with great results.  

Grateful, if you have had great results, why are you still on Gleevec 600mg?  that's a high dosage.  Are you PCRU?


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


#7 survenant

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Posted 07 December 2015 - 04:24 PM

See also  Generic Gleevec 



#8 ChrisC

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Posted 07 December 2015 - 05:28 PM

Good news for some re Novartis's card for those with private insurance to not start using the generic Gleevec?

 

http://www.webmd.com...leevec-approved

 

First Generic Version of Gleevec Approved by FDA

WebMD News from HealthDay

Dec. 7, 2015 -- The first generic version of the cancer drug Gleevec (imatinib mesylate) has been approved by the U.S. Food and Drug Administration.

The agency approved 100-milligram and 400-milligram pills of the generic version to treat chronic myeloid leukemia. The once-a-day pills are made by Sun Pharmaceutical Industries Ltd. of India, which said U.S. sales of the pills will begin Feb. 1, 2016, the Associated Press reported.

The FDA gave Sun exclusive rights to sell generic Gleevec for six months. If the FDA approves other drug companies' generic versions, there should be a significant drop in the cost.

Gleevec -- sold by Novartis -- costs about $10,000 a month for the 400-milligram daily dosage. Novartis is trying to limit the number of U.S. patients who start using the generic version by offering patients with private insurance discount cards that cap their monthly co-payment at $10, with the drug company paying up to $30,000 a year of the pharmacy tab. Insurers would have to cover the rest of the bill, the AP reported.

Patients who pay cash or those with government coverage are not eligible.


Be alert, but not overly concerned.

 

• Dx Oct. 22, 2008, WBC 459k, in ICU for 2 days + in hospital 1 week

• Leukapheresis for 1 week, to reduce WBC (wasn't given Hydroxyurea)

• Oct. 28, 2008: CML confirmed, start Gleevec 400mg

• Oct. 31, 2008: sent home when WBC reached 121k

• On/off, reduced dose Gleevec for 7 months

• April 2009: Started Sprycel 100mg

• Sept. 2009: PCRU 0.000

• Sept. 2011: after 2 years steady PCRU & taking Sprycel 100mg before bed, quit Sprycel (with permission)

• Currently: still steady PCRU, testing every 6 months 🤗

— Fatigue, hearing loss continue, alas, but I prefer to think it is all getting better!

 

 


#9 rcase13

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Posted 07 December 2015 - 05:45 PM

So will this cause any drop in the price of other TKIs?

10/01/2014 100% Diagnosis (WBC 278k, Blasts 6%, Spleen extended 20cm)

01/02/2015 0.06% Tasigna 600mg
04/08/2015 0.01% Tasigna 600mg
07/01/2015 0.01% Tasigna 600mg
10/05/2015 0.02% Tasigna 600mg
01/04/2016 0.01% Tasigna 600mg
04/04/2016 PCRU Tasigna 600mg
07/18/2016 PCRU Tasigna 600mg
10/12/2016 PCRU Tasigna 600mg
01/09/2017 PCRU Tasigna 600mg
04/12/2017 PCRU Tasigna 600mg
10/16/2017 PCRU Tasigna 600mg
01/15/2018 PCRU Tasigna 600mg

 

Cancer Sucks!


#10 Grateful9771

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Posted 07 December 2015 - 10:49 PM

When I was first diagnosed in 2009 I spent quite a bit of time on this site.  When it became clear that I was having a good response to the medication, I decided to continue my great health care, work hard,  and most importantly enjoy life.   I don't think about my CML very much.   Anticipating my upcoming retirement and the concern addressing the cost of my monthly mediation has inspired me to return to the site and find out what others are doing.  Several years ago I became aware that there was some success in discontinuing the medicine and remaining in remission.  My Oncologist and I have discussed this on several occasions.  My last blood work resulted in a MMR of 4.5 - 5.  Unfortunately when I was diagnosed in 2009 I had 5 of 20 transcripts which showed the number 8 mutation.   Due to the number 8 mutation in my original diagnosis, my Doctor is being very conservative in how he approaches my therapy.  With the success of my reaction to the Gleevec he doesn't want to interrupt the therapy that is working.  In the back of his mind, and of course mine, I have the number 8.  He doesn't want to do anything which will cause the the mutation to kick in and mess with the success we have had to date.  As more studies result in new findings, I believe he and I will both be open to trying something new.  For example the most recent studies showing 100% of those who relapsed returned to MMR with in 4 months is very encouraging.   Bottom line is this - I have the number 8 mutation.  In 2009 that was really quite terrifying.   Most people catch their CML prior to the 8 mutation forming.  It would be interesting to know, if anyone who has ceased the medication had any mutations in their original diagnosis.  






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