FDA Accepts sNDA for Darolutamide Plus ADT in mHSPC

[Heykm01]

targetedonc.com/view/fda-ac...

Any guesses on how long approval might take?

[OldGuysRule]

I agree 100%! I was diagnosed in 2015 and been metastatic for 2.5 years now and on Lupron since then. I quit Zytiga 6 months because I hated it. My wife and I decided to take a break from ADT because my recent dexa bone scan revealed that I have developed osteoporosis after only 2 years. I could that my bones were becoming damaged. I have been faithful to weight bearing exercise, taking calcium with vitamin D. I am looking forward to break.

I

[duckcalldan]

It will be interesting to find out. I started ADT 4 weeks ago, and I used the ARANOTE phase 3 results to encourage my MO to approve Orgovyx + Nubeqa as my doublet combo. I had a BAD reaction to prednisone many years ago so I wasn’t thrilled about doing the lupron, abitaterone & pred trio. Luckily my insurance approved Nubeqa ($14K/month!) and Orgovyx is coming free from the manufacturer. SEs are mild so far, mainly mild/moderate hot flashes and constipation.