How long before FDA approves Nubeqa for doublet?

[vintage42]

The FDA has accepted a supplemental new drug application (sNDA) seeking the approval of darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The sNDA is supported by data from the phase 3 ARANOTE trial… If approved, this would expand the indication for [darolutamide] in patients with mHSPC to include [darolutamide] both with and without chemotherapy.

onclive.com/view/fda-accept...

[Brad70]

I am taking Nubeqa with Eligard (Lupron). No chemo. I was told my IMRT is a substitute for chemo.

[j-o-h-n in reply to Brad70]

The three musketeers. Me, lupron and nubeqa....

Good Luck, Good Health and Good Humor.

j-o-h-n

[dhccpa in reply to Brad70]

Interesting. I'm doing IMRT now. Are you on Medicare? And did you get pre-approval from your insurance, private or otherwise.

[Brad70 in reply to dhccpa]

I have Medicare including part D and a supplemental plan from United Healthcare (AARP). I applied to the Bayer Patient Assistance Program. They send me Nubeqa for free.

[dhccpa in reply to Brad70]

Thanks, I'll check it out. I assume there's income limitations of some sort.

[PELHA]

That would be great. The side effect profile seems better but husband couldn’t do this as on doublet for meta cancer. Though he seems ok with Erleada. More options always a plus.

[V10fanatic]

An additional arrow in our quiver is always a good development. Hope this happens.