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News on PARP inhibitors???

Alnik
Posts: 56
Joined: Feb 2012

Does anyone have any info on status of FDA approval of any of the PARP inhibitors. Olaparib i believe falls in that catagorie Ive heard realy great things about them. Ive headr rumor of approval as soon as Jan. 2014 Unfortanetly my cancer is growing throughtout my active treatment hoping to get some info on other options. Thank You

2timothy1 7's picture
2timothy1 7
Posts: 348
Joined: Jan 2012

Hello

I've been on olaparib for 6 months now successfully through a trial at the National Institute of Health. They cover my flights there. It has been great for me so far. The drug is very tolerable! If you have any further questions I will be happy to answer them.

 

i don't know about FDA approval time line. However, you might look into one of the triials.

Best of luck to you,

Shawnna

 

Alnik
Posts: 56
Joined: Feb 2012

I read somewhere that if you had a allergic  reaction to carboplatium you may not be consider for the parp drugs do you know if there is any truth to that. I had a severe reaction on my 8th infusion of carbo/taxol. I know i have meet the other critia for being considered to receive it. Keeping my fingers crossed!!!!

Alexandra's picture
Alexandra
Posts: 1316
Joined: Jul 2012

Hi Alnik,

For now the only way to get PARP inhibitors is through the trials. There are multiple stage 2 / stage 3 clinical trials going on for Olaparib, Niraparib, Rucaparib, Iniparib, Veliparib as single agents and in combination with chemotherapy both for recurrence and maintenance in ovarian cancer, 3neg breast cancer, colorectal cancer. 

They are years away from FDA approval. It is possible that FDA will make an exception and approve PARP drugs for BRCA positive patients sooner. It's more of my wishful thinking than the fact. Read the link below: http://globenewswire.com/news-release/2013/06/01/551320/10034686/en/AstraZeneca-Advances-PARP-Inhibitor-Into-Phase-3-Trial-With-BRACAnalysis-R.html

In trials where PARP inhibitor is given in combination with Carboplatin, I can imagine that you being allergic could disqualify you. But if PARP is given as single agent, I don't think you will have a problem with eligibility.

Good luck!

 

2timothy1 7's picture
2timothy1 7
Posts: 348
Joined: Jan 2012

I've not heard anything about allergies to carboplatnum being an exclusion criteria. I think your have to be off chemo for at least 4 weeks before you are considered.

 

There is a trial that uses olaparib and carboplatnum . This may be what you have heard about. However my trial is olaparib only. I randomized into it. The other arm of it was olaparib and cederanib.

 

hope a you can get into a trial.

Best wishes to you.

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