Darolutamide Should Be Available in 2018

[gusgold]

Good news if you failed Xtandi because Apalutamide has similar chemical structure and Darolutamide does not...Darolutamide works on mutated AR's and AR-V7

prostatecancernewstoday.com...

Gus

[joancarles]

Thank you very much for the information.

Are they applicable drugs if you already have bone metastases? Is it valid to use it when Zytiga fails?

[Hidden in reply to joancarles]

I read that the ARAMIS trial was for non-metastatic CRPC because apparently that are no approved treatments for this relatively small group of people (as compared to the MCPRC population). I just hope we can get it approved for the metastatic people who make up the vast majority of CRPC patients.

I'm wondering whether it will be considered as "off-label" use. Hopefully the doctors will prescribe it and insurance companies will pay. Otherwise it will be out of reach for most of us. Enzalutamide is already very expensive, I can imagine this could even be more expensive.

[gusgold in reply to Hidden]

Schumer, the SOB, was the only nay vote On Right To Try Law in the Senate...said was in favor but wanted more time...good chance Right To Try passes in 2018 so that would be a way to obtain Darolutamide with mCRPCa

Gus

[Hidden in reply to gusgold]

From what I understand, many states including mine already have Right to Try laws. Everything I've read indicates that these laws don't force Pharma companies to provide the drug so they can just say No. Unless of course it's an Opiate and then they say Yes to everyone whether they need it or not.

[Bobkar in reply to joancarles]

My brother 61 yo stage 4 Mets to all bones Gleason score 8 is in the trial.

[Hidden]

Getting tested for AR-V7 may be a way to get approval since the Zytiga and Enzalutamide are typically ineffective with this mutation. You might have to use either one of them first though. It is a positive development. We are one step closer to getting it.

[gusgold]

If your doc is willing to be creative in the paperwork you should be able to obtain it.

[joancarles]

I will take your information very seriously.

[gusgold]

crazy...both Apalutamide and Darolutamide for moCRPCa...so right now if you fail Xtandi, Zytiga, and chemo the only options are Colt .45 or wrestle Gustave...pic below of Hippo with PCa....myself I am going with Gustave as soon as I fail Darolutamide

Gus

i.pinimg.com/736x/af/29/48/...

[Dan59 in reply to gusgold]

Myself I will just keep plugging away, living my life and having as much fun as I can.

[tarhoosier]

The release referred to above does not say darolutamide will be available this year. It is a report of an update from the trial that the primary completion will now be in September 2018, a change from March, 2018. It is not indicated on the clinicaltrials.gov website when the change was made. The study completion date is now June 30, 2020 which has moved forward from December 2020. Once the final patient has received an intervention or placebo that is the primary completion date. Results ready for publication lag a year or two after that (or more). The application for successful drugs, then federal consideration and so on follow on from there.

[podsart]

Gus

Do you hve access to the entire article? When I try to access this, I only get 1st couple lines, then pushed into a "pay for" the rest--which seems to be a monthly charge. Do you subscribe to this?

[rococo]

Thanks for another lutamide

[Bobkar]

Yes!!! My brother is on the trial. Just started last month. Hoping that if you are participating in the trial you can automatically have access to the drug when approved. Does anyone have knowledge of this process?