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Orion, Bayer prostate cancer drug gets FDA approval

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Posted 8/1/2019 8:12 AM (GMT -5)
Finland's Orion and Germany's Bayer said on Wednesday the US Food and Drug Administration (FDA) had approved the androgen receptor inhibitor Nubeqa (daroluramide), which the two companies have been developing together, for use in men with non-metastatic, castration-resistant prostate cancer.
Posted 8/1/2019 8:55 AM (GMT -5)
https://www.targetedonc.com/news/darolutamide-approved-by-fda-for-nonmetastatic-crpc
Posted 8/1/2019 1:13 PM (GMT -5)

I'm THANKFUL any time there is a breakthrough or new approval that can help one of our comrades.

Every new medication or treatment is a STEP FORWARD, and for that, I give true thanks.

Speed the plow, researchers and scientists!

Thanks for the new update,
CYCLONE ~ Iowa State University
Posted 8/1/2019 5:44 PM (GMT -5)
Whether insurance will cover crossed my mind. Bayer is offering a 2-month free trial program and $0 co-pay support. Go to: https://www.nubeqa-us.com/
Posted 8/1/2019 7:13 PM (GMT -5)
The next step is for Medicare reimbursement approval. Most FDA approvals also get Medicare approval, but it is based on cost benefit analysis and whether there is already another drug in the space. Once Medicare approves the drug for reimbursement, then most insurance companies generally follow suit. Most often takes several months.
Posted 8/1/2019 8:39 PM (GMT -5)
Question:
Better than other androgen receptor inhibitors???
Posted 8/1/2019 8:57 PM (GMT -5)
"Every new medication or treatment is a STEP FORWARD, and for that, I give true thanks."

Not necessarily true..Sometimes the existing treatments work just as well for less money..The fact that Bayer is offering a guarantee of sorts is a step in the right direction..
Posted 8/2/2019 5:50 AM (GMT -5)
This was approved after the Phase 3 trial with 1509 men under the FDA Priority Review program. In other words it was fast tracked. It will compete against Xtandi.

I could not find any pricing information, but one financial report stated it should be worth more than a billion dollars a year for Bayer. Assume cost will be similar to Xtandi and Zytiga. Based on the FDA approval Bayer is also asking for fast track approval in Europe and Japan.

It will be interesting to see how Medicare and then the other third party payors handle reimbursement. If it is Medicare approved then third party pay payors will have an option as they already reimburse for at least one of the cancer drugs in this class.
Posted 8/2/2019 7:36 AM (GMT -5)
you know what would be interesting to know how many dollars goes out for wages and benefits, taxes, buildings, and just the everyday cost of doing business before a drug like this one gets approved by FDA. This drug may or not be cheaper than other drugs but it might offer a hope to someone that has become resistant to other drugs.

Larry
Posted 9/6/2020 11:35 PM (GMT -5)
I’m starting Nubeqa tonight after xtandi didn’t work for me after 4-5 months. Got the two-month trial at no charge. Fingers crossed, though doc says chances of it working are around 20% given that xtandi didn’t work for me. Worth a try and I’ll keep you posted.
Posted 9/7/2020 2:41 AM (GMT -5)
Best wishes Steve. My recollection is that you are the first in the forum to use it.
Posted 9/7/2020 7:19 AM (GMT -5)

Hello, 55777 ~~~

Thank you, for blazing a new trail. I want to wish you success with the new medication, and appreciate your willingness to share your experience.

Over time --- it's amazing how many times members on this website have documented their experiences with "cutting edge" treatments and medications, that then became standard treatment.

I am thinking back to the first fellows here who were among the very first patients to try PROVENGE, XOFIGO, ZYTIGA, and XTANDI ... to name just a few.

Right here ... we then learned from each other on the possibilities that the "early chemo plan" provided ... new genetic testing possibilities ... and then individually formulated "chemotherapy cocktails" ... and the list goes on!

These experiences then become part of the archives here.

Quite often, we hear from a new member, who starts out their first post by saying, "I have been reading past posts about ... "

So, here's to success with the new medication, and mild side effects, as well!

We'll await updates from you, Steve55777!

Thanks for blazing a new trail for others ----
CYCLONE ~ # Iowa State University
Posted 9/7/2020 10:08 AM (GMT -5)
Steve, my best hope for your good response to the medication!
Posted 9/8/2020 1:36 PM (GMT -5)
Xtandi did not work because you had Zytiga before. There is a cross-resistance between the drugs. Unfortunately I would also expect a cross-resistance with Nubeqa as well because it is similar to Xtandi. I hope this is not the case for you. You should not mention the metastases on the PSMA PET/CT because Nubeqa is for non-metastatic patients only.
Cabacitaxel will work now and then you can try Nubeqa.
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